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 2010-01-08 for M3733A manufactured by Philips Medical Systems.
[21398270]
This customer reported that she was booted out of the retrospective review of the 96 hours of ecg data. The involved patient died. The customer has stated that there is no relationship between this reported issue and the patient's outcome.
Patient Sequence No: 1, Text Type: D, B5
[21430831]
This customer reported that she was booted out of the retrospective review of the 96 hours of ecg data. The involved patient died. The customer has stated that there is no relationship between this reported issue and the patient's outcome. A follow-up report will be submitted after philips obtains more information about this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2010-00023 |
| MDR Report Key | 1574239 |
| Report Source | 05,06,07 |
| Date Received | 2010-01-08 |
| Date of Report | 2009-12-11 |
| Date of Event | 2009-12-11 |
| Date Mfgr Received | 2009-12-11 |
| Date Added to Maude | 2010-01-11 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTIE DESCHENES |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | NA |
| Product Code | MLO |
| Date Received | 2010-01-08 |
| Model Number | M3733A |
| 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 ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-01-08 |