MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK COMBO; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	11996
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 failure 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 their device electrode accessory failed to provide defibrillation.This issue is patient related; however there was no adverse event reported.The customer indicated a back up device was used and the patient survived and is neurologically intact.
Event or Problem Description
The customer contacted physio-control to report that their device electrode accessory failed to provide defibrillation.This issue is patient related; however there was no adverse event reported.The customer indicated a back up device was used and the patient survived and is neurologically intact.
Additional Manufacturer Narrative
Physio-control evaluated the customers device however the electrodes were not returned with the unit and can not be evaluated.The reported issue was unable to be verified and unable to be duplicated.Root cause is unable to be determined.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.

• Brand Name: QUIK COMBO
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11634830
• Report Number: 0003015876-2021-00722
• Device Sequence Number: 3658251
• Product Code: DRX
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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 Expiration Date: 07/13/2023
• Device Model Number: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 103642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1