MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-20 for MORTARA manufactured by Mortara Instrument, Inc.
[120860608]
The customer provided 2 pdf files of the ecg obtained on (b)(6) 2018 at 07:32:26. The first pdf is an ecg with an unconfirmed, device provided interpretation of atrial fibrillation and nonspecific t-wave abnormality. In the second pdf, the physician followed the expected workflow. He removed the interpretation statement provided by the device based on his over-read of the patient's waveform. The physician added his interpretation analysis to the ecg and then electronically signed the report. The physician's interpretation of the ecg did not include atrial fibrillation. He read the ecg as sinus rhythm with first degree av block with occasional superventricular premature complexes, nonspecific t-wave abnormality. Per the devices instructions for use, the interpretation statement provided by the device is for consideration only after review by a physician, to be used in conjunction with all other relevant patient data and is not a sole means for diagnosis and/or treatment. The customer was contacted multiple times; however, no additional information regarding this event could be obtained.
Patient Sequence No: 1, Text Type: N, H10
[120860609]
The customer acquired an electrocardiogram (ecg) with the eli 380. The interpretation statement provided by the eli 380 device stated atrial fibrillation. Based on the interpretation statement, the patient was given a calcium channel blocker. The customer alleges that the patient experienced a cardiac arrest secondary to medication. Review of the ecg waveform showed that the patient was not in atrial fibrillation and therefore the patient may not have required the calcium channel blocker. Per the physician the patient did not have atrial fibrillation but did have sepsis and sinus tachycardia. It is unknown whether the patient had any risk factors for cardiac arrest in addition to the calcium channel blocker. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183461-2018-00003 |
| MDR Report Key | 7893696 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-20 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK ELLIOTT |
| Manufacturer Street | 7865 NORTH 86TH STREET |
| Manufacturer City | MILWAUKEE WI 532243431 |
| Manufacturer Country | US |
| Manufacturer Postal | 532243431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MORTARA |
| Generic Name | ELECTROCARDIOGRAPH |
| Product Code | DPS |
| Date Received | 2018-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MORTARA INSTRUMENT, INC |
| Manufacturer Address | 7865 NORTH 86TH STREET MILWAUKEE WI 532243431 US 532243431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-09-20 |