MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-03-06 for HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION 805249-06 manufactured by Physio-control, Inc..
[19531358]
While picking random samples from different lots for testing, physio-control engineering discovered damaged coating on 10 internal paddles. There have been no field complaints and no service reports during this period. There is an impact to the intended internal paddles device performance. Current flowing from the defect can cause local tissue damage due to thermal heating or due to electroporation. Current flowing from the back of the paddle shunts current from the intended therapeutic path, rendering defibrillation ineffective. This analysis indicates that harm may be caused to the patent due to thermal heating and electroporation. Current shunting is small enough to preclude any significant impact on shock efficacy.
Patient Sequence No: 1, Text Type: D, B5
[19665099]
Physio-control continues to investigate the reported failure 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
| Report Number | 3015876-2009-00270 |
| MDR Report Key | 1377609 |
| Report Source | 06,07 |
| Date Received | 2009-03-06 |
| Date of Report | 2009-02-06 |
| Date of Event | 2009-02-06 |
| Date Facility Aware | 2009-02-06 |
| Report Date | 2009-02-06 |
| Date Mfgr Received | 2009-02-06 |
| Date Added to Maude | 2009-07-30 |
| 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 | HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION |
| Generic Name | 74DRX |
| Product Code | DRL |
| Date Received | 2009-03-06 |
| Model Number | NA |
| Catalog Number | 805249-06 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC. |
| Manufacturer Address | REDMOND WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-06 |