MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-06-04 for LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR 805300 manufactured by Physio-control, Inc..
[20630595]
It was reported that the device would reset by itself. There was no pt use associated with the reported failure.
Patient Sequence No: 1, Text Type: D, B5
[20831509]
(b) (4): physio-control evaluated the device and verified the reported failure; however, due to the age of the device and the costs associated with repair, the customer declined service. The cause of the reported failure could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2010-00711 |
| MDR Report Key | 1713788 |
| Report Source | 05,06,07 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-07 |
| Date of Event | 2010-05-07 |
| Date Mfgr Received | 2010-05-07 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2010-06-16 |
| 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 | ANA SZUCS |
| Manufacturer Street | 11811 WILLOWS ROAD NE PO BOX 97006 |
| Manufacturer City | REDMOND WA 980739706 |
| Manufacturer Country | US |
| Manufacturer Postal | 980739706 |
| Manufacturer Phone | 4258674000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR |
| Product Code | LOS |
| Date Received | 2010-06-04 |
| Returned To Mfg | 2010-05-07 |
| Model Number | 11 |
| Catalog Number | 805300 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |