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

Model Number 11996

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/15/2021

Event Type  malfunction  

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 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 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.

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
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11634830
• MDR Text Key: 244438476
• Report Number: 0003015876-2021-00722
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (y/n): N
• PMA/PMN Number: K943301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1