MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for LIFEPAK 9 803800-300 manufactured by Physio Control Corp..
[6355]
Patient went into v fib. The defibrillator was brought to the cardiac cath table. The nurse pressed the charge button & screen faded out with no power. The connections were checked, recharge again, plug checked. After third attempt the patient lost consciousness. A new defibrillator was brought converted to nsr. The macine had been checked one hour previously. The test strip taken to biomed with the machine. Biomed ran unit for 3 days and tried to make machine fail but was unable to duplicate occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17760 |
| MDR Report Key | 17760 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-03-10 |
| Date of Event | 1994-02-16 |
| Date Facility Aware | 1994-02-16 |
| Report Date | 1994-03-10 |
| Date Reported to Mfgr | 1994-03-10 |
| Date Added to Maude | 1994-11-16 |
| 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 |
| 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 9 |
| Generic Name | MONITOR/DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1994-07-29 |
| Model Number | 803800-300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17677 |
| Manufacturer | PHYSIO CONTROL CORP. |
| Manufacturer Address | 11811 WILLOWS RD. NE REDMOND WA 98073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-07-29 |