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

Model Number	15
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker 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.Stryker contacted the customer to request additional information on the patient.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
The customer contacted stryker to report that their device's main keypad does not function.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse event reported.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify the reported issue.After replacing the main keypad, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Stryker further evaluated the replaced parts at the product assessment center (pac).The cause of the reported issue was determined to be contamination between the switch dome and the pcb gold trace from common cleaning product ingredients.
Event or Problem Description
The customer contacted stryker to report that their device's main keypad does not function.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.This issue is patient related; however, there was no adverse event reported.

• Brand Name: LIFEPAK® 15 DEFIBRILLATOR/MONITOR
• 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: 14678086
• Report Number: 0003015876-2022-01014
• Device Sequence Number: 4818582
• Product Code: MKJ
• UDI-Device Identifier: 00883873912799
• UDI-Public: 00883873912799
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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): 09/01/2022

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: 99577-001217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2013
• 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