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	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.Upon evaluation of the customer¿s device, stryker observed that the device had logged an event code in the memory which is related to a potential issue of the device to deliver defibrillation energy.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and verified the reported issue.Stryker replaced the device¿s main keypad assembly.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.Based on the information available, stryker has determined that the likely cause of the reported issue was that the shock switch located on the main keypad assembly was out of tolerance due to excessive resistance.When this issue occurs, an event code will be logged in the device's memory following a failure of the device to deliver defibrillation energy.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 14585748
• Report Number: 0003015876-2022-00838
• Device Sequence Number: 20213127
• Product Code: MKJ
• UDI-Device Identifier: 00883873911617
• UDI-Public: 00883873911617
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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 Model Number: 15
• Device Catalogue Number: 99577-001257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2015
• 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: 3015876-11/18/2019-001C
• Patient Sequence Number: 1
• Patient Sex: Unknown