MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-18 for LIFEPAK 7 DEFIBRILLATOR/MONITOR 801380 manufactured by Physio-control, Inc..
[805314]
Defibrillation charge inoperative lp7 will not charge and no heart rate.
Patient Sequence No: 1, Text Type: D, B5
[7933979]
Customer to scrap device due to age and unavailability of parts. A root cause can not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2008-00692 |
| MDR Report Key | 984433 |
| Report Source | 05 |
| Date Received | 2008-01-18 |
| Date of Report | 2007-12-12 |
| Report Date | 2007-12-12 |
| Date Added to Maude | 2008-08-19 |
| 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 |
| 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 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK 7 DEFIBRILLATOR/MONITOR |
| Product Code | DRK |
| Date Received | 2008-01-18 |
| Model Number | 7 |
| Catalog Number | 801380 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 986010 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-18 |