MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for LEAD WIRE SET RUBBER GASKET manufactured by Philips Medical Systems.
[53556058]
Gasket came loose in the part of the lead set that connects to the telemetry pack. This caused failure of the patient's ekg signal to transmit to the central station. Telemetry pack worked fine with a new lead set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064375 |
| MDR Report Key | 5910106 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-19 |
| Date Added to Maude | 2016-08-29 |
| 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 |
| 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 | LEAD WIRE SET RUBBER GASKET |
| Generic Name | ECG 5 LEAD GRABBER, AAMI SPO2 TEL |
| Product Code | DSA |
| Date Received | 2016-08-24 |
| Lot Number | 3015 GMDN 35562 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ANDOVER ME 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-24 |