MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-19 for QUIK-COMBO? PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECHNOLOGY UNK_SMP manufactured by Physio-control, Inc. - 3015876.
[142513103]
(b)(4). The customer submitted a voluntary medwatch report to the fda: mw5085226. 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. Device evaluated by mfr: device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[142513104]
It was reported to physio-control through a medwatch report regarding quick-combo pacing/defibrillation/ecg electrodes: "apparent failure of three electrodes, same lot# in a cardiac arrest resulted in significant delay in the defibrillation of a patient. The patient died; it is as yet undetermined whether this was a direct result of the delay in defibrillation, or due to other causes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00691 |
| MDR Report Key | 8532176 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-19 |
| Date of Report | 2019-08-16 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2019-02-26 |
| Date Added to Maude | 2019-04-19 |
| 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. TODD BANDY |
| 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 | 3 |
| Brand Name | QUIK-COMBO? PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECHNOLOGY |
| Generic Name | EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES |
| Product Code | MLN |
| Date Received | 2019-04-19 |
| Returned To Mfg | 2019-05-02 |
| Catalog Number | UNK_SMP |
| Lot Number | 826053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Death | 2019-04-19 |