MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO ELECTRODES WITH REDI-PAK PRECONNECT SYSTEM; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Model Number	QUIK-COMBO ELECTRODES
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.   physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
The customer contacted physio-control to report that therapy electrodes on their device were not working.In this state the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse event reported.
Event or Problem Description
The customer contacted physio-control to report that therapy electrodes on their device were not working.In this state the device may not be able to provide defibrillation therapy, if it were needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The customer reported to physio-control that their quik-combo electrodes did not work, when attempting to provide synchronized cardioversion.Initially, the same pads were used on 3 different devices, and subsequently the electrodes with the same lot number were used on subsequent patients, with the same problem.When a different lot number electrodes were subsequently used, the users were able to provide defibrillation therapy.The customer confirmed they still had two of the three electrode sets used during the event.Additionally, the customer still had unused, closed packages of electrodes with the same lot number.The customer's electrodes were returned to the physio-control product assessment center (pac).The pac evaluated the electrodes and confirmed proper operation for both the used and the unused electrodes.For each it was confirmed they were able to provide defibrillation therapy, as expected.A cause of the reported issue could therefore not be determined.

• Brand Name: QUIK-COMBO ELECTRODES WITH REDI-PAK PRECONNECT SYSTEM
• Common Device Name: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10792556
• Report Number: 0003015876-2020-01645
• Device Sequence Number: 19776367
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K960329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QUIK-COMBO ELECTRODES
• Device Catalogue Number: 11996-000091
• Device Lot Number: 010428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 20 DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK® 20 DEFIBRILLATOR/MONITOR, MKJ
• Patient Age: 60 YR