MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY; EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES

Catalog Number	11131-000013
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer's paddles will be returned for the further evaluation.Stryker continues to investigate the reported issue 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 internal paddles were pealed off.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s internal paddles at the product assessment center (pac) and verified the reported issue.The dielectric epoxy coating on the edge of both internal paddle plates shows discrepancies, as the dielectric epoxy coating is partially delaminated / peeled off.A root cause of the reported issue could not be established.The customer's internal paddles were archived by stryker.
Event or Problem Description
The customer contacted stryker to report that their internal paddles were pealed off.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.

• Brand Name: QUIK-COMBO¿ PACING/DEFIBRILLATION/ECG ELECTRODES WITH EDGE SYSTEM¿ TECHNOLOGY
• Common Device Name: EXTERNAL PACING/DEFIBRILLATION/ECG ELECTRODES
• 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: 15455386
• Report Number: 0003015876-2022-02096
• Device Sequence Number: 17868042
• Product Code: MLN
• UDI-Device Identifier: 00883873824771
• UDI-Public: 00883873824771
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K960329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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: 11131-000013
• Device Lot Number: 0921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 01/20/2023
• 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