MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-06 for HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION 11110-000035 manufactured by Physio-control, Inc. - 3015876.
[104932144]
(b)(4). Physio-control advised the customer that the internal paddles should be permanently removed from service and a replacement be obtained. Neither the device nor the internal paddles were returned to physio-control for evaluation. The cause of the reported issue could not be determined. Device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[104932145]
The customer contacted physio-control to report that a set of internal paddles being used in conjunction with their lifepak 12 device would not shock when they first attempted to shock a patient. The internal paddles did shock the patient on the third or fourth attempt. There were no reports of adverse effects to the patient as a result of the reported issue. Physio-control has made multiple attempts to contact the customer in order to obtain additional information about the patient and the event; however, no response has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2018-00561 |
| MDR Report Key | 7403710 |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-06 |
| 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 Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2018-04-06 |
| Model Number | NA |
| Catalog Number | 11110-000035 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Address | 11811 WILLOWS ROAD NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |