MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-05-10 for OB TRACEVUE SERVER M1383D manufactured by Philips Medical Systems.
[16099749]
The customer reported that although they could visually see alarms, they were unable to hear the alarms.
Patient Sequence No: 1, Text Type: D, B5
[16116526]
(b)(4): the customer reported that although they could visually see alarms, they were unable to hear the alarms. Based on the current information, the hospital staff conducted tests on alerts in obtv and appear to be functioning. The customer rebooted the internal server and confirmed that the archiving and alerting are back to "normal" functioning. In the absence of audio functions, users may not be aware of the need for emergent care, therefore, there may be a health risk. Philips is in the process of obtaining additional information regarding this incident and the complaint is still under investigation. A final report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610816-2011-00234 |
| MDR Report Key | 2126056 |
| Report Source | 05,06,07 |
| Date Received | 2011-05-10 |
| Date of Report | 2011-04-26 |
| Date Mfgr Received | 2011-04-26 |
| Date Added to Maude | 2011-07-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OB TRACEVUE SERVER |
| Product Code | HFM |
| Date Received | 2011-05-10 |
| Model Number | M1383D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-10 |