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

Model Number	20E
Medical Device Problem Codes	Failure to Power Up (1476); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
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.Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.
Event or Problem Description
The customer contacted stryker to report that their device failed to provide defibrillation therapy.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
The device was not returned to stryker for evaluation.Stryker has made multiple attempts to contact the customer regarding the status of their device, but no response has been received from the customer.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device failed to provide defibrillation therapy.This issue is patient related; however there was no adverse event reported.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and was unable to verify or duplicate the initial reported issue reported issue.During evaluation stryker also observed the on/off button was not responding.After completing other unrelated repairs, proper device operation was observed through functional and performance testing and the device returned to the customer for use.Further root cause could not be determined.
Event or Problem Description
The customer contacted stryker to report that their device failed to provide defibrillation therapy.This issue is patient related; however there was no adverse event reported.

• Brand Name: LIFEPAK® 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: 16264708
• Report Number: 0003015876-2023-00152
• Device Sequence Number: 4403015
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 02/22/2024

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: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 02/21/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 04/21/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2017
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White