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

Model Number	15
Medical Device Problem Codes	Failure to Power Up (1476); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that the on button of their device would work intermittently.This issue may prevent the device from providing therapy if it were needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Section h6 device code grid of initial mdr indicates: key or button unresponsive, not working.Section h6 device code grid of initial mdr should indicate: failure to power up.Section b5 executive summary of initial mdr indicates: the customer contacted stryker to report that the on button of their device would work intermittently.This issue may prevent the device from providing therapy if it were needed.There was no patient use associated with the reported event.Section b5 executive summary of initial mdr should indicate: the customer contacted stryker to report that the device does not consistently power up when connected to acpa.This issue may prevent the device from providing therapy if it were needed.There was no patient use associated with the reported event.Stryker provided the customer with a new ac adapter.The customer confirmed to the stryker sales representative that the device would function properly using the new ac adapter.Stryker determined that the likely cause of the reported issue was due to process adhesive on one of the device¿s ac input pcbs.This can trigger the overvoltage protection of the ac power adapter and may result in the device being unable to power on or charge the batteries.
Event or Problem Description
The customer contacted stryker to report that the on button of their device would work intermittently.This issue may prevent the device from providing therapy if it were needed.There was no patient use associated with the reported event.

• 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: 19085769
• Report Number: 0003015876-2024-00736
• Device Sequence Number: 7651448
• Product Code: MKJ
• UDI-Device Identifier: 00883873871874
• UDI-Public: 00883873871874
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: 99577-001939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-10/13/2023-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown