MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-11-12 for HEARTSTART MRX M3535A manufactured by Philips Medical Systems.
[5297785]
It was reported to philips healthcare that the device had an ecg equip malfunction inop message and ecg bias errors in the status log. There was no reported pt involvement or negative pt impact.
Patient Sequence No: 1, Text Type: D, B5
[12496372]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-06831 |
| MDR Report Key | 4268076 |
| Report Source | 99 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-10-27 |
| Date Mfgr Received | 2014-10-27 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2014-11-25 |
| 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 | PHYLLIS MCCARTHY |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786592811 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART MRX |
| Product Code | MJK |
| Date Received | 2014-11-12 |
| Returned To Mfg | 2014-11-03 |
| Model Number | M3535A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-11-12 |