MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-23 for COVIDIEN ADAPTER REF 33541 33541 manufactured by Covidien.
[68526932]
Telemetry monitor showed ventricular tachycardia. When pt was attached to defibrillator the rhythm showed normal sinus rhythm. Telemetry monitor continued to show ventricular tachycardia. Telemetry monitor, leads and pads were changed and rhythm then showed normal sinus rhythm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068138 |
| MDR Report Key | 6360793 |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-18 |
| Date Added to Maude | 2017-02-27 |
| 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 | COVIDIEN ADAPTER |
| Generic Name | ADAPTER |
| Product Code | DRW |
| Date Received | 2017-02-23 |
| Model Number | REF 33541 |
| Catalog Number | 33541 |
| Lot Number | 278428 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |