MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-06-12 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[15309440]
Philips healthcare received a complaint from a durable medical equipment (dme) supplier stating that a smart monitor 2 device failed to alarm. The dme stated that the patient was found blue and transported to the hospital where the patient was successfully resuscitated with no lasting impact.
Patient Sequence No: 1, Text Type: D, B5
[15481719]
The smart monitor 2 device is designed to monitor respiration, and heart rate. Upon detection of abnormal events, smart monitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. Based on a complete review of the complaint allegation, philips healthcare has determined that the reported issue requires further investigation. Once the device is returned for investigation or additional information is received, a follow-up additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: N, H10
[27427172]
Multiple attempts were made to obtain additional information about the reported incident and to obtain the product back for evaluation. Two people were contacted at the customer site. One did not have any additional information about the event, but did have a copy of the device download, which provides data showing when the device was in use and when the device was alarming. This same person also contacted the patient? S parents for more information related to the time of the actual event, but claimed that the parents did not remember this information. The other person at the customer site stated that the device will not be returning for evaluation and did not have any additional information about the event. The device download obtained showed that the device was in use from 6:22am to 12:52pm and again from 1:32pm to 1:56pm on (b)(6) 2015. The device alarmed for a tachycardia at 6:23am and a bradycardia at 12:50pm while in use, but without knowing the time of the alleged incident it can? T be confirmed if the device was in use or alarming at the time of the alleged failure. Because the product was not returned for evaluation and the time of the incident is unknown, the reported problem cannot be confirmed. The product remains at the customer site. Evaluation of the device download showed that the device was in use during certain time periods on the day of the reported incident and the device alarmed multiple times while in use. The investigation could not determine whether the product caused or contributed to the reported patient outcome because the customer did not return the device for evaluation or know the time of the incident for comparison with the device download. Therefore, we are considering this to be a malfunction of insufficient information/unknown cause for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
[27427173]
Philips healthcare received a complaint from a (b)(4) supplier stating that a smart monitor 2 device failed to alarm. The (b)(4) stated that the patient was found blue and transported to the hospital where the patient was successfully resuscitated with no lasting impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2015-03134 |
| MDR Report Key | 4840649 |
| Report Source | 08,DISTRIBUTOR |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-28 |
| Date of Event | 2015-05-14 |
| Date Mfgr Received | 2015-05-28 |
| Date Added to Maude | 2015-06-12 |
| 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 | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-06-12 |
| Model Number | 4003 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-12 |