MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,foreign,user facility report with the FDA on 2015-08-03 for LIFEPAK(R) 5 DEFIBRILLATOR 9-00285 manufactured by Physio-control, Inc.
[6250511]
It was reported to physio-control that the customer's device did not shock during patient treatment. There was patient use associated with the reported event however, no information regarding the patient outcome was provided. No further information on the event or patient details were provided.
Patient Sequence No: 1, Text Type: D, B5
[14221036]
(b)(4). Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: N, H10
[28353456]
Physio-control performed several attempts to obtain more information regarding the reported event and to have the device returned for evaluation. No response was received and the device was not returned to physio-control for evaluation. A cause of the reported issue could therefore not be returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2015-00949 |
| MDR Report Key | 4959815 |
| Report Source | 01,06,FOREIGN,USER FACILITY |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-13 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-09-21 |
| Device Manufacturer Date | 1986-05-19 |
| Date Added to Maude | 2015-08-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JASON MARCH |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | PHYSIO-CONTROL, INC |
| Manufacturer Street | 11811 WILLOWS ROAD NE PO BOX 97006 |
| Manufacturer City | REDMOND WA 980739706 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 980739706 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEPAK(R) 5 DEFIBRILLATOR |
| Generic Name | DC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) |
| Product Code | DRK |
| Date Received | 2015-08-03 |
| Model Number | 5 |
| Catalog Number | 9-00285 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 29 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC |
| Manufacturer Address | 11811 WILLOWS ROAD NE PO BOX 97006 REDMOND WA 980739706 US 980739706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-03 |