MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-26 for LIFEPAK 6 DEFIBRILLATOR 800260 manufactured by Physio-control, Inc..
[15008946]
According to the reporter, the device's power switch will not stay in the on position, and you have to hold the button to keep the device powered on. He said he called for the switch part number because he thinks they have one in stock.
Patient Sequence No: 1, Text Type: D, B5
[15526567]
Physio-control supplied customer with parts information. The reporter stated he did have a new switch in his stock. He said he replaced the on/off switch and then observed proper device operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2008-01002 |
| MDR Report Key | 1138544 |
| Report Source | 05,06 |
| Date Received | 2008-08-26 |
| Date of Report | 2008-07-29 |
| Date of Event | 2008-07-29 |
| Date Facility Aware | 2008-07-29 |
| Report Date | 2008-07-29 |
| Date Mfgr Received | 2008-07-29 |
| Device Manufacturer Date | 1982-06-01 |
| Date Added to Maude | 2008-11-10 |
| 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 6 DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 2008-08-26 |
| Model Number | 6 |
| Catalog Number | 800260 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 26 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1269959 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-26 |