MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Catalog Number 11996-000090

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY
• Type of Device: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: meg marseglia ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 8368692
• MDR Text Key: 137132704
• Report Number: 0003015876-2019-00314
• Device Sequence Number: 1
• Product Code: MLN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K960329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11996-000090
• Device Lot Number: 821822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1