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 2008-08-18 for LIFEPAK 6S PATIENT MONITOR 801555 manufactured by Physio-control, Inc..
[939127]
It was reported that the device's power switch did not function and the device would not power on. There were no reports of pt use associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8073576]
The customer confirmed that they have decided to take the device out of service, due to its poor condition. The device will not be returned to physio-control for evaluation. The root cause of the reported failure cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2008-00958 |
| MDR Report Key | 1128645 |
| Report Source | 05,06,07 |
| Date Received | 2008-08-18 |
| Date of Report | 2008-07-18 |
| Date of Event | 2008-07-18 |
| Date Mfgr Received | 2008-07-18 |
| Date Added to Maude | 2008-11-04 |
| 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 RD., N.E. 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 6S PATIENT MONITOR |
| Product Code | DRK |
| Date Received | 2008-08-18 |
| Model Number | 6 |
| Catalog Number | 801555 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1262147 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-18 |