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	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted stryker to report that the controls on the main keypad of their device were unresponsive.As a result, defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was able to duplicate the reported issue.After replacing the keypad assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
Additional Manufacturer Narrative
Corrected data: section b5, executive summary of the initial medwatch report indicates: there was no patient use associated with the reported event.Section b5, executive summary of the initial medwatch report should indicate: this issue is patient related; however, there was no adverse patient outcome reported.Section h11, additional mfg narrative of the initial medwatch report indicates: stryker evaluated the customer's device and was able to duplicate the reported issue.After replacing the keypad assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Section h11, additional mfg narrative of the initial medwatch report should indicate: stryker evaluated the customer's device and was able to duplicate the reported issue.After replacing the keypad assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Section h6, health impact code grid of the initial medwatch report indicates: no patient involvement, 2645 section h6, health impact code grid of the initial medwatch report should indicate: no health consequences or impact, 2199.Additional manufacturer narrative: stryker contacted the customer to request additional information on the patient.Stryker requests patient information necessary for regulatory compliance, strictly adhering to hipaa's privacy rule.The customer informed stryker that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.
Event or Problem Description
A customer contacted stryker to report that the controls on the main keypad of their device were unresponsive.As a result, defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse patient outcome reported.

• 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: 19784364
• Report Number: 0003015876-2024-02225
• Device Sequence Number: 8371671
• Product Code: MKJ
• UDI-Device Identifier: 00883873871683
• UDI-Public: 00883873871683
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/21/2025

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: 99577-001958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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