MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-04-27 for HEARTSTREAM FR2 M3860A manufactured by Philips Medical Systems.
[5822280]
It has been reported that device voice prompts are not functioning correctly.
Patient Sequence No: 1, Text Type: D, B5
[13327288]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3030677-2015-01055 |
| MDR Report Key | 4736645 |
| Report Source | 01,04 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-09 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2015-06-09 |
| 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 | DANA TACKETT |
| Manufacturer Street | 22100 BOTHELL-EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4259082503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTREAM FR2 |
| Generic Name | AED |
| Product Code | MJK |
| Date Received | 2015-04-27 |
| Model Number | M3860A |
| Operator | OTHER |
| 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 | 2015-04-27 |