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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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
The customer contacted stryker to report that their defibrillation pads did not deliver shock on two attempts during patient use.The customer further advised new lot of defibrillation pads were used and shock successfully delivered to patient.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker evaluated customer's electrodes from the same lot and was unable to verify or duplicate the reported issue.The cause of the reported issue could not be conclusively determined.The customer has been provided with replacement electrodes.The returned electrodes have been archived by stryker.
Event or Problem Description
The customer contacted stryker to report that their defibrillation pads did not deliver shock on two attempts during patient use.The customer further advised new lot of defibrillation pads were used and shock successfully delivered to patient.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: 15591453
• Report Number: 0003015876-2022-02264
• Device Sequence Number: 2263449
• Product Code: DRX
• UDI-Device Identifier: 00883873784969
• UDI-Public: 00883873784969
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 221684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFEPAK® 20E DEFIBRILLATOR/MONITOR, MKJ
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG