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	11996-000091
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker was notified that the customer submitted a voluntary medwatch report (reference report number mw5107075).The following was reported: "defibrillator pads were applied to patient and were going to be used as initial assessment of rhythm; however, pads did not pick up rhythm.2 sets of defibrillator pads did not function correctly." this mdr is for the first electrodes used.The medwatch report from the customer indicates intervention was required.However, the description of event has no evidence of an adverse patient outcome.
Additional Manufacturer Narrative
Stryker 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.Per medwatch report (reference report number mw5107075), patient information is not releasable.The device nor the electrodes were returned to stryker for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Additional Manufacturer Narrative
The customer provided patient and updated information.Section a, fields a1, a2, and a3; section b field b5 and section d field c2/d10 concomitant product have been updated.
Event or Problem Description
Stryker was notified that the customer submitted a voluntary medwatch report (reference report number mw5107075).The following was reported: "defibrillator pads were applied to patient and were going to be used as initial assessment of rhythm; however, pads did not pick up rhythm.2 sets of defibrillator pads did not function correctly." the patient was in asystole and no shock was required.This mdr is for the first electrodes used.The customer reported that the patient did pass away.The customer confirmed that there was no injuries to the patient as a result of the equipment failure.The issue was strictly with the pads and not other associated equipment.The patient did pass away but there were extenuating circumstances that led or caused the patient to pass away per physician notes.

• 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: 13897360
• Report Number: 0003015876-2022-00431
• Device Sequence Number: 19909233
• Product Code: DRX
• UDI-Device Identifier: 00883873784945
• UDI-Public: 00883873784945
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K943301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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 Catalogue Number: 11996-000091
• Device Lot Number: 0305019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/08/2022
• 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: LP20E (B)(6).
• Patient Age: 68 YR
• Patient Sex: Female