MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-02-25 for QUIK-COMBO? PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECHNOLOGY 11996-000090 manufactured by Physio-control, Inc. - 3015876.
[137132704]
(b)(4). Physio-control was made aware by the customer that they performed their own investigation of the reported event. After the event, the initial quik-combo defibrillation electrodes were placed on a staff member and connected to the first defibrillator used in the event. There was no connection made. The same defibrillation electrodes were connected to the second device used during the event and again no connection was made. Upon connecting and reconnecting the defibrillation electrodes numerous times, a slight ecg trace/noise on the display of the monitor was observed. It was noted that connection was observed only when the connector of the quik-combo defibrillation electrodes was squeezed tightly at the connection point between the defibrillation electrodes and the defibrillation therapy cable of the device(s). A new set of quik-combo defibrillation electrodes were placed on another staff member and immediately a connection was made with both defibrillators used during the event. The quik-combo defibrillation electrodes used during the event were discarded. The device(s) and the quik-combo defibrillation electrodes used during the event were not returned to physio for evaluation. The root cause of the reported issue could not be determined. Device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[137132765]
The customer contacted physio-control to report that during a patient event a set of their quik-combo defibrillation electrodes was unable to detect the patient. The customer checked their device, the defibrillation therapy cable, the connection between the defibrillation therapy cable and the quik-combo defibrillation, and the electrode pad adhesion to the patient but there was still no connection between the device and the patient. The customer advised that the device prompted them to? Connect electrodes? When the defibrillation electrodes were connected to the patient. The same quik-combo defibrillation electrodes was used with a second device and again a connection was not made. A new set of quik-combo defibrillation electrodes was used with the second device and then a connection was made. The customer was able to successfully deliver 200 joules to the patient. There was approximately 2 minutes of delay. This issue is patient related; however there was no adverse patient outcome reported. Physio-control has attempted to contact the customer for further information on the event and patient, but has been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00314 |
| MDR Report Key | 8368692 |
| Report Source | FOREIGN |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-02-05 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-02-25 |
| 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 | QUIK-COMBO? PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM? TECHNOLOGY |
| Generic Name | EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES |
| Product Code | MLN |
| Date Received | 2019-02-25 |
| Model Number | NA |
| Catalog Number | 11996-000090 |
| 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 | 2019-02-25 |