MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-27 for FAST-PATCH? PLUS DISPOSABLE DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECH 11996-000093 manufactured by Physio-control, Inc. - 3015876.
[137394013]
(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. Device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[137394014]
The customer contacted physio-control to report that they were using this device on a patient and had pediatric defibrillation electrodes connected to the patient. The defibrillation electrodes kept peeling off of the patient so they switched to a new set of defibrillation electrodes. The new set of defibrillation electrodes were also peeling off of the patient. As a result, defibrillation therapy may have been delayed or unavailable, if it was needed. The customer switched to a back up device and another set of defibrillation electrodes and was able to continue patient care. There were no reports of any adverse effects to the patient as a result of the reported issue. Physio-control contacted the customer to request additional information on the patient. No response has been received from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00330 |
| MDR Report Key | 8376559 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-27 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-02-27 |
| 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. 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 | FAST-PATCH? PLUS DISPOSABLE DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECH |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) |
| Product Code | MLN |
| Date Received | 2019-02-27 |
| Catalog Number | 11996-000093 |
| Lot Number | 734530 |
| Device Expiration Date | 2019-06-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-27 |