MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-07-07 for HEARTSTART FR3 989803149941 manufactured by Philips Medical Systems.
[48970976]
A health hazard evaluation was completed and it was determined that no new or additional risk has been identified. (b)(4). Udi #: unknown.
Patient Sequence No: 1, Text Type: N, H10
[48970977]
It has been reported that during in-house testing, philips observed that the? Hands-off? Icon is not displayed when expected on the cpr meter when in use with the fr3 device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3030677-2016-01573 |
| MDR Report Key | 5775511 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-07-07 |
| Date of Report | 2016-06-17 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-07-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DANA TACKETT |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980218431 |
| Manufacturer Country | US |
| Manufacturer Postal | 980218431 |
| Manufacturer G1 | PHILIPS HEALTHCARE - BOTHELL |
| Manufacturer Street | 22100 BOTHELL-EVERETT HWY BLDG A |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART FR3 |
| Generic Name | CPR METER |
| Product Code | LIX |
| Date Received | 2016-07-07 |
| Model Number | 989803149941 |
| ID Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-07 |