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 2010-09-28 for M1383D manufactured by Philips Medical Systems.
[1472581]
The customer reported that there was a failure to alarm. No pt harm was reported.
Patient Sequence No: 1, Text Type: D, B5
[8738008]
(b)(4). The customer reported that there was a failure to alarm. No pt harm was reported. Philips is in the process of obtaining additional info concerning this event 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 | 9610816-2010-00527 |
| MDR Report Key | 1850075 |
| Report Source | 05,06,07 |
| Date Received | 2010-09-28 |
| Date of Report | 2010-08-05 |
| Date Mfgr Received | 2010-08-05 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2010-11-29 |
| 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 | GREG THEOKAS |
| Manufacturer Street | 3000 MINUTEMAN RD |
| 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 |
| Product Code | HFM |
| Date Received | 2010-09-28 |
| 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 | HEWLETT-PACKARD STR. 2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-28 |