MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-21 for QUIK-COMBO? PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECHNOLOGY 11996-000091 manufactured by Physio-control, Inc. - 3015876.
[145621589]
(b)(4). Physio-control contacted the customer but was unable to obtain further information. The device and the defibrillation electrodes used during the event were not returned to physio 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
[145621590]
Physio-control was notified that the customer submitted a voluntary medwatch (medsun) form (reference report number mw5085996). The customer reported the following,? During resuscitation aed used once without issue, about 20 minutes later aed shock was attempted again, this time resulting in electrical arc and fire, patient had minor burns to body. Patient moved and resuscitation continued for about 10 minutes, patient pronounced when resuscitation was unsuccessful.? The patient did not survive, however the customer, a healthcare provider stated that the patient outcome was due to the patient? S condition and not the result of the device use. Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer said she could not provide any further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00881 |
| MDR Report Key | 8626358 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-05-21 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MEG MARSEGLIA |
| 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 | 2019-05-21 |
| Catalog Number | 11996-000091 |
| Lot Number | 835511 |
| 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 | 2019-05-21 |