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

Catalog Number	11101-000021
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker 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
A customer contacted stryker to report that the device would not detect the electrodes being connected.As a result, defibrillation therapy would not be available, if needed.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the issue of the electrodes not connecting correctly with the device.Upon inspection, it was observed that the device kept resetting after the lid is opened.The device can no longer be repaired.The customer was provided with a replacement device.The cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that the device would not detect the electrodes being connected.As a result, defibrillation therapy would not be available, if needed.There were no reports of patient use associated with the reported event.

• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17403530
• Report Number: 0003015876-2023-01338
• Device Sequence Number: 5837634
• Product Code: DRX
• UDI-Device Identifier: 00883873867808
• UDI-Public: 00883873867808
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: 11101-000021
• Device Lot Number: 210210-3698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown