MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for PHILIPS LEADS M1968A manufactured by Philips Medisize Costa Mesa, Llc.
[128405934]
It was reported that the ekg leads stopped working while on pt during a robotic procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081572 |
| MDR Report Key | 8101684 |
| Date Received | 2018-11-23 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-11-20 |
| Date Added to Maude | 2018-11-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PHILIPS LEADS |
| Generic Name | CABLE TRANSDUCER AND ELECTRODE, PATIENT |
| Product Code | DSA |
| Date Received | 2018-11-23 |
| Model Number | M1968A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDISIZE COSTA MESA, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-23 |