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 2013-09-27 for HEART START XL M4735A manufactured by Philips Medical Systems.
[15203420]
The customer states the pacing output is lower than it should be. Discovered issue during routine maintenance. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[15601597]
(b)(4). A follow up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2013-04772 |
| MDR Report Key | 3492703 |
| Report Source | 05,06,07 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-09-03 |
| Date Mfgr Received | 2013-09-03 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2014-01-03 |
| 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 | DENYSE MURPHY |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597844 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART START XL |
| Product Code | MJK |
| Date Received | 2013-09-27 |
| Model Number | M4735A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-09-27 |