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	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their electrodes did not work as expected.In this state the device would be inoperable and defibrillation therapy would not be available if needed.They were able to open to successfully use another set of electrodes.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.Device not returned to manufacturer.

• 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: 16131185
• Report Number: 0003015876-2023-00037
• Device Sequence Number: 3199803
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/10/2023

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 Model Number: 11996
• Device Catalogue Number: 11996-000017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LP 20E DEFIBRILLATOR/MONITOR, MKJ, SN (B)(4)
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White