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

Model Number	11996
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.The cause of the reported issue could not be conclusively determined.The electrodes used during reported event are not available for evaluation.Electrodes disposed of by customer.
Event or Problem Description
The customer contacted stryker to report that their defibrillation electrodes did not connect to their device as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker received additional patient information from the customer.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Concomitant products grid updated with concomitant device serial number: (b)(6).
Event or Problem Description
The customer contacted stryker to report that their defibrillation electrodes did not connect to their device as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however there was no adverse event reported.

• Brand Name: QUIK COMBO
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 15212354
• Report Number: 0003015876-2022-01858
• Device Sequence Number: 17288535
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K943301
• 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): 09/07/2022

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: 11996
• Device Catalogue Number: 11996-000091
• Device Lot Number: 209423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ; LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ, 32188875
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic