MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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	12/05/2023
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 would not power on with dc or ac power.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative evaluated the customer's device and was able to verify and duplicate the reported issue of no ac operation.The stryker technician was not able to duplicate the issue with the dc operation; the stryker technician was able to power on device using known good dc battery the stryker technician replaced the power supply (eos) and the power pcb assembly from the power module to resolve the issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The removed part was further evaluated by stryker product analysis center (pac).The pac technician confirmed a shorted transistor on the eos.The root cause for no ac operation was determined to be a shorted transistor on the eos.No root cause was determined for no dc operation.
Event or Problem Description
The customer contacted stryker to report that their device would not power on with dc or ac power.As a result, defibrillation therapy would not be available, if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 20E 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18371653
• Report Number: 0003015876-2023-02448
• Device Sequence Number: 7767110
• Product Code: MKJ
• UDI-Device Identifier: 00883873887790
• UDI-Public: 00883873887790
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/23/2024

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: 20E
• Device Catalogue Number: 99507-000093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2014
• 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