MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2014-10-16 for HEARTSTART ONSITE M5066A manufactured by Philips Medical Systems.
[20976116]
It has been reported that the aed did not pass self-diagnostic check.
Patient Sequence No: 1, Text Type: D, B5
[21301810]
(b)(4). Product evaluation pending. Issue is being reported as alert could not be cleared by operator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3030677-2014-02328 |
| MDR Report Key | 4184420 |
| Report Source | 01,04 |
| Date Received | 2014-10-16 |
| Date of Report | 2014-09-19 |
| Date Mfgr Received | 2014-09-19 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2014-10-29 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DARREN DEMERRITT |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980218431 |
| Manufacturer Country | US |
| Manufacturer Postal | 980218431 |
| Manufacturer Phone | 4259082672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART ONSITE |
| Product Code | MJK |
| Date Received | 2014-10-16 |
| Model Number | M5066A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 98021843 US 98021 8431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-16 |