MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided stryker with all the available patient information.Patient fields in which information was not provided were intentionally left blank.Stryker performed and initial evaluation of the customer's device and was unable to duplicate the reported issue.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 when they delivered a shock for synchronized cardioversion to a patient, their device froze.The users had to power cycle the device to continue monitoring the patient.In this state, the device could delay or prohibit the delivering of defibrillation therapy to a patient if needed.The customer advised that the was no harm to the patient as cardioversion was achieved.
Event or Problem Description
The customer contacted stryker to report that when they delivered a shock for synchronized cardioversion to a patient, their device froze.The users had to power cycle the device to continue monitoring the patient.In this state, the device could delay or prohibit the delivering of defibrillation therapy to a patient if needed.The customer advised that the was no harm to the patient as cardioversion was achieved.
Additional Manufacturer Narrative
Stryker further evaluated the customer's device and was unable to duplicate the reported issue.Stryker replaced the therapy pcb assembly as a precaution.After observing proper device operation through functional and performance, the device was returned to the customer for use.Stryker downloaded and evaluated the electronic records from the device and was able to verify the reported issue, however, the cause of the reported issue could not be determined.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18129937
• Report Number: 0003015876-2023-02110
• Device Sequence Number: 7790455
• Product Code: MKJ
• UDI-Device Identifier: 00883873871768
• UDI-Public: 00883873871768
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 01/04/2024

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: 15
• Device Catalogue Number: 99577-001950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2021
• 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
• Patient Sex: Unknown