MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for HANDLES AND CONNECTOR WITH DISCHARGE CONTROL 3010901-006 manufactured by Physio-control, Inc.
[95745384]
(b)(4). 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
[95745385]
The customer contacted physio-control to report that their device would not recognize the internal paddles during a patient event. The customer disconnected the internal paddles and connected the therapy cable, which worked. The internal paddles were connected to another device and they were still not recognized. Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer advised that no further details are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3015876-2017-01631 |
| MDR Report Key | 7134362 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-12-06 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2017-12-20 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TODD BANDY |
| Manufacturer G1 | PHYSIO-CONTROL, INC |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| 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 | 0 |
| Brand Name | HANDLES AND CONNECTOR WITH DISCHARGE CONTROL |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-12-20 |
| Returned To Mfg | 2018-01-04 |
| Catalog Number | 3010901-006 |
| Lot Number | 1709 |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC |
| Manufacturer Address | 11811 WILLOWS ROAD NE REDMOND WA 980739706 US 980739706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |