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	Ventricular Fibrillation (2130)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device was unable to deliver defibrillation therapy during a patient event.The customer advised that the device was charged to 100j, when "synch" was pressed the monitor flickered, then the screen turned black.After a few seconds the screen returned.The device was charged to 100j, then dumped, and charged to 360j when monitor flickered again and power cycled.The service indicator was then illuminated.In addition the device logged a potentially critical event code that is indicative of a device lockup.This issue is patient related; however the patient was saved by the medics.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with all the available patient information.Stryker evaluated the customer¿s device but was unable to duplicate the reported issue.The device software was reloaded as a precaution.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.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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 13389380
• Report Number: 0003015876-2022-00122
• Device Sequence Number: 1738169
• Product Code: MKJ
• UDI-Device Identifier: 00883873912799
• UDI-Public: 00883873912799
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2014
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White