MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for LARGE SWITCHLESS INTERNAL PADDLES M1742A manufactured by Philips Medical Systems.
[129465231]
A follow-up report will be submitted once the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[129465232]
The customer reported that the internal paddles are scratched. There was no patient or user involvement.
Patient Sequence No: 1, Text Type: D, B5
[132907572]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-09488 |
| MDR Report Key | 8134047 |
| Date Received | 2018-12-05 |
| Date of Report | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-12-05 |
| 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 | MS. JACQUELINE NISHINO |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| 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 | 0 |
| Brand Name | LARGE SWITCHLESS INTERNAL PADDLES |
| Generic Name | NA |
| Product Code | LDD |
| Date Received | 2018-12-05 |
| Model Number | M1742A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-05 |