MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	20E
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
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.
Event or Problem Description
The customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that their device does not power on.In this state the device may not be able to deliver defibrillation therapy, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The report of no ac or dc power was not confirmed as the stryker technician was able to power on the device with a known good dc battery.The technician replaced the eos and pcba from the power module to repair the device.The device passed performance inspection procedure and was returned to the customer for use.The pac technician evaluated the faulty pcba and confirmed a shorted transistor on the eos was causing the issue of no ac operation and no dc battery charge.The root cause for no ac operation is an inoperative eos.No root cause was determined for no dc operation.

• Brand Name: LIFEPAK® 20E DEFIBRILLATOR/MONITOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 17996797
• Report Number: 0003015876-2023-01955
• Device Sequence Number: 6754139
• Product Code: MKJ
• UDI-Device Identifier: 00883873887660
• UDI-Public: 00883873887660
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• 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): 11/27/2023

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: 20E
• Device Catalogue Number: 99507-000106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2014
• 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 Sex: Unknown