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	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control will contact the customer to request additional information on the patient.The customer provided physio-control with the information on the electrodes used during the event; however, the monitor/defibrillator information has not been provided.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 they were using their device on a patient and the device was unable to deliver a shock to a patient with a ventricular fibrillation rhythm.There were no reports of any adverse effects to the patient as a result of the reported issue.
Event or Problem Description
The customer contacted physio-control to report that they were using their device on a patient and the device was unable to deliver a shock to a patient with a ventricular fibrillation rhythm.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
The customer received a replacement device.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.H3 other text : device not evaluated by manufacturer.

• 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: 11641490
• Report Number: 0003015876-2021-00733
• Device Sequence Number: 2987308
• Product Code: DRX
• UDI-Device Identifier: 00883873784938
• UDI-Public: 00883873784938
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943301
• 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): 04/12/2022

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 Expiration Date: 07/13/2023
• Device Model Number: 11996
• Device Catalogue Number: 11996-000090
• Device Lot Number: 103642
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LIFEPAK MONITOR/DEFIBRILLATOR, MKJ; UNKNOWN LIFEPAK MONITOR/DEFIBRILLATOR, MKJ
• Patient Sex: Unknown