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 Codes	Burn(s) (1757); Ventricular Fibrillation (2130)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.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 or Problem Description
The customer contacted physio-control to report that their device failed to deliver shock while in use with a patient.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Section h5 of initial mfr 0003015876-2021-02037, labeled for single use, states no.Section h5 has been updated to yes.The customer returned all unused electrodes of the same lot to stryker redmond for evaluation.All electrodes performed normally when tested, and no defects in adhesion or gel were detected.The electrodes were applied to the technician's skin for over 2 hours with no adhesion loss or redness when removed.Stryker was unable to replicate issue.No root cause could be determined.
Event or Problem Description
The customer contacted physio-control to report that their device failed to deliver shock while in use with a 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: 12677592
• Report Number: 0003015876-2021-02037
• Device Sequence Number: 1245741
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/29/2022

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: 11999
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 20/20E DEFIBRILLATOR/MONITOR, MKJ
• Patient Sex: Unknown