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

Catalog Number	11996-000091
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that their defibrillation electrodes were unable to adhere to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Due to character limitations, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).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.Though stryker requested some patient information, stryker will not request any information which can identify, directly or indirectly, a person to be in accordance with regulation (eu) (b)(4) of the (b)(6) parliament and of the council.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.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s electrodes at the product assessment center (pac) and the technician was able to confirm through visual inspection that the gel of both pads appeared to be partially adhered to the clear plastic film/backing.Functional testing has been performed and several energy levels have been delivered without error messages, however the measured values of the delivered energy were lower than the selected energy levels.A cause of the reported issue could not be determined.
Event or Problem Description
A customer contacted stryker to report that their defibrillation electrodes were unable to adhere to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

• Brand Name: QUIK-COMBO¿ ELECTRODES WITH REDI-PAK¿ PRECONNECT SYSTEM
• 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: 14090595
• Report Number: 0003015876-2022-00558
• Device Sequence Number: 5721072
• Product Code: MKJ
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K960329
• 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): 01/09/2023

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: 11996-000091
• Device Lot Number: 004828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 01/09/2023
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG