MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-18 for LIFEPAK 8 MONITOR MODULE manufactured by Physio-control Corporation.
[15221]
This patient had cabg 10/21/94. Post-op persistant arrythmias. 10/26/94 during cardioversion procedure the synchronizing mode button failed, causing on ecg reading similating synchronization with the patient's heart rate. After second shock patient had 15 minutes of vt which spontaneously resolved. Pacing leads adjusted, shocked with 100j and patient converted to nsr. Patient remained in nsr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25230 |
| MDR Report Key | 25230 |
| Date Received | 1995-01-18 |
| Date of Report | 1994-10-27 |
| Date of Event | 1994-10-26 |
| Date Facility Aware | 1994-10-26 |
| Report Date | 1994-10-27 |
| Date Reported to Mfgr | 1994-10-28 |
| Date Added to Maude | 1995-09-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK 8 MONITOR MODULE |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1995-01-18 |
| Model Number | LIFEPAK 8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25693 |
| Manufacturer | PHYSIO-CONTROL CORPORATION |
| Manufacturer Address | 11811 WILLOWS RD. NORTHEAST P.O. BOX 97048 REDMOND WA 98073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1995-01-18 |