MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-12-07 for LIFEPAK 5 DEFIBRILLATOR 801528 manufactured by Physio-control, Inc..
[768900]
The customer reported that the defibrillator fails to charge above 50 joules. There was no pt use associated with the reported event.
Patient Sequence No: 1, Text Type: D, B5
[8034250]
The customer indicated the device had been forwarded to a local medical equipment engineering facility for eval. The customer was advised that the device was no longer supported and replacement parts were no longer available. The device ceased being marketed in 12/1990.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2007-00570 |
| MDR Report Key | 961469 |
| Report Source | 01,05 |
| Date Received | 2007-12-07 |
| Date of Report | 2007-11-07 |
| Date Mfgr Received | 2007-11-07 |
| Device Manufacturer Date | 1984-03-01 |
| Date Added to Maude | 2008-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | BILL GARTHE |
| Manufacturer Street | 11811 WILLOWS RD., N.E. PO BOX 97006 |
| Manufacturer City | REDMOND WA 980529706 |
| Manufacturer Country | US |
| Manufacturer Postal | 980529706 |
| Manufacturer Phone | 4258674000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK 5 DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 2007-12-07 |
| Model Number | 5 |
| Catalog Number | 801528 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 23.5 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966886 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-07 |