MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-03-04 for QUIK-COMBO? ELECTRODES WITH REDI-PAK? PRECONNECT SYSTEM 11996-000017 manufactured by Physio-control, Inc. - 3015876.
[137796384]
(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
[137796385]
The customer contacted physio-control to report that defibrillation electrodes were connected to a patient and there was extreme "noise" on the monitor that would have interfered with interpreting the patient's rhythm and delivery of a shock, if it were required. There were no adverse effects to the patient as a result of the reported issue. No further details about the patient or the event were provided. Physio-control attempted to contact the customer in order to obtain additional information on the patient; however, no response has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00373 |
| MDR Report Key | 8388612 |
| Report Source | FOREIGN |
| Date Received | 2019-03-04 |
| Date of Report | 2019-08-15 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-07-17 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-03-04 |
| 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? ELECTRODES WITH REDI-PAK? PRECONNECT SYSTEM |
| Generic Name | EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES |
| Product Code | MLN |
| Date Received | 2019-03-04 |
| Model Number | NA |
| Catalog Number | 11996-000017 |
| Lot Number | 821822 |
| 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 | 2019-03-04 |