MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-18 for HEART CARD 5258-10 * manufactured by Instromedix Inc.
[16617043]
Add'l info rec'd from mfr 12/18/02: actions taken: mfr queried install base and determined the number of units in the field to be 673 and the date range of manufacturing for this model to be from march to august 1999. Notified president of the incident and followed up with the logging of a formal customer complaint into quality system and notifying parent company card guard. Through the install base records mfr contacted customer navix diagnostix, a cardiac monitoring service provider, who purchased the device new in march 1999 and asked to have the device returned for evaluation and provide mfr any records they might have on this unit. The device was received at instromedix on december 03, 2002, photographed, and the ecg stored in the device memory downloaded and reviewed. The recording appeared to be normal with a slightly noisy baseline, however it was later determined to be from the next pt to receive the device (navix was unaware at the time that an incident report was pending). The device was then sent to service dept for complete evaluation and testing. The testing procedure used is the same procedure used for final product acceptance in production. The results appear to be normal for this device and no anomalies (except for a slightly oxidized electrode foot) noted. The device meets instromedix product specifications based upon the testing performed. A copy of the complaint investigation along with the photographs has been filed with this complaint. Technical service personnel then contacted the person who originally filed the incident report with the fda and faxed them a request for release of the pt's name authorizing navix to release to instromedix the actual ecg data recorded for mfr to evaluate. This individual and rebuffed mfr's efforts to date and is unwilling to sign a release authorization. Navix, citing pt confidentiality will not provide the ecg data to instromedix without written consent, however they have stated verbally to technical service personnel that data received on the date in question from this serial numbered device appeared to be normal and restated their confidentiality requirements. They also indicated this serial number had been successfully used by 35 pts prior the reported incident and by one pt after for a total of 37 patients. Navix was then asked if there were any other issues with using heartcard monitors and they indicated that there are no issues with using heartcards and in fact they "really love" the heartcard monitors. Mfr sent a copy of complaint investigation and ecg data from internal testing to present company for physician review. A cory of medical director and professional cardiologist's report was received and has been filed with this complaint along with a copy of personal credentials. He states that as the device is a single lead cardiac event recorder it was neither designed nor indicated for use in chest pain monitoring and cannot predict or diagnose a heart attack. A review of all customer complaints for this model was performed. One complaint was recorded aug 30, 1999 by (then owner of instromedix) alaris medical systems. This was recorded erroneously as the customer returned the sample device they had been loaned for evaluation without any negative comments or concerns. No other customer complaints have been filed on this model number. A medwatch mandatory 30 day report (fda form 3500a sections d,g,h) and medical device baseline report (fda form 3417) are being filed with the appropriate agencies. Conclusions: the complaint is without merit. The reported malfunction (maude event report (foi) mw1026739 event description b5) of the heartcard "device failed to detect a major heart attack in progress" is in conflict with the indications for use of the device. The device functions according to specification.
Patient Sequence No: 1, Text Type: D, B5
[18185590]
Device failed to detect a major heart attack in progress. This happened twice. Pt was experiencing shortness of breath and difficulty walking. Rptr wants to know if the fda wants the device for its evaluation. The heart attack was so severe that pt almost died that evening at the emergency room. Rptr was told there had been other complaints to fda concerning this particular device or similar ones. Device was rented to pt for a period of 30 days (use of the device is a covered medicare benefit). Rptr wishes and explanation of the difference between fda registration and approval of a medical device: whatever or not this particular device is registered and/or approved by the fda; confirmation that the fda has no means of testing defective medical devices and confirmation that rental of this device is a covered medicare benefit. In this particular case, the device was used twice after heart attack symptoms appeared. Pt placed it on their chest to record the status of their heart and transmitted the recording to the company twice. The company and their cardiologist at the time both stated twice that the recording was normal. According to rptr the device created a false sense of security and delayed treatment during a life-threatening heart attack. This raises a question about whether the device should be recalled, and its medicare benefit status reviewed, to determine whether or not the device should remain on the market.
Patient Sequence No: 1, Text Type: D, B5
[22167335]
Add'l info rec'd from rptr 11/19/02: for several years, pt has had intermittent episodes of what dr called "palpitations", and lightheadedness, particularly after meals or when climbing stairs. About six months ago, dr prescribed cardizem cd 180mg, daily for this condition. The drug seemed to alleviate the incidents and reduce their frequency. After another incident in october, dr ordered the "heart card" (a cardiac event monitor) in an apparent attempt to record whatever could be elarned if and when such an incident occurred again. When pt received the device they read the instructions carefully and tested the card several times by placing the card on their chest, pressing the record button and then transmitting the recording to the 800 number of the vendor. Pt became confident that they could use the card correctly. Preliminary summary of events on 11/1/02: on event day pt was on route to lunch with a friend in the park when the first symptom began shortness of breath, a symptom that persisted, and gradually worsened throughout the afternoon, and was coupled with lightheadedness and progressively more extreme weakness in both legs. At lunch, the shortness of breath worsened and lightheadedness also occurred. Pt used the cardiac event monitor to record and transmit cardiac status. The vendor reported that the recording was normal. As the symptoms worsened, about 2:30pm pt recorded and transmitted the event again, again the response of the vendor was that the event was normal. Pt and friend started walking out of park to find a taxicab and go to pt's home. Pt had to sit down every few steps. Pt told their friend their legs were weak, that they felt light-headed and had some abnormal sensation in throat. At one point, pt almost fell. Pt leaned on a fence, on a tree, and on their friend. Later they took a cab to pt's apartment about 3pm. A doorman at pt's building later reported that as pt entered building, accompanied by their friend, pt was walking abnormally and staggering. Pt called dr about 3:15pm and about 5:15pm. Both transmissions had been sent to him by the vendor and he pronounced both normal. At one point pt was sitting on the floor in their apartment. When they tried to stand up, they could not do so, and sat down or fell to the floor. Pt tried to rise and could not do so. 911 was called. An ambulance arrived, emergency medical technicians checked blood pressure, and vital signs, administered oxygen and carried pt in a chair to an ambulance that took them to the er, where they were diagnosed with congestive heart failure and almost died. Rptr feels the vendor's device twice failed to detect a heart attack in progress, lulled pt into a sense of false confidence about their cardiac status, and delayed emergency diagnosis and treatment. Rptr feels this device should be recalled promptly by the fda before it kills someone and the center for medicare and medicaid services should review its medicare benefit status, to determine whether or not the device should remain on the market as a covered benefit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026739 |
| MDR Report Key | 428429 |
| Date Received | 2002-11-18 |
| Date of Report | 2002-11-18 |
| Date of Event | 2002-11-01 |
| Date Added to Maude | 2002-11-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART CARD |
| Generic Name | CARDIAC MONITOR |
| Product Code | DXH |
| Date Received | 2002-11-18 |
| Model Number | 5258-10 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 417452 |
| Manufacturer | INSTROMEDIX INC |
| Manufacturer Address | * HILLSBORO OR * US |
| Baseline Brand Name | HEARTCARD |
| Baseline Generic Name | TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE |
| Baseline Model No | 5258-10 |
| Baseline Catalog No | 5258-10 |
| Baseline Device Family | HEARTCARD |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K944362 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-11-18 |