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

Model Number	20E
Medical Device Problem Codes	Failure to Charge (1085); Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.   stryker continues to investigate the reported issue 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 did not charge when they attempted to provide defibrillation to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
A stryker service representative performed evaluation of the customer¿s device and was not able to verify or duplicate the reported issue.The technician tested the defibrillation energy charge and delivery with both hard paddles and the therapy cable and determined that the device charged and delivered in specification on all energy ranges tested.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.A customer quality engineer reviewed the electronic device records and observed that a shock was not delivered to the patient after the charge was successfully completed.Page 4-19 of the operating instructions for the lifepak 20e states "confirm that a triangle sense marker appears near the middle of each qrs complex.If the sense markers do not appear or are displayed in the wrong locations (for example, on the t-wave), select another lead.(it is normal for the sense marker location to vary slightly on each qrs complex.)" the pco file from the reported event date showed that the triangle sense markers were not displayed on the middle of the qrs complexes of the ecg signal.As a result, energy was not delivered when the user pressed the shock button.
Event or Problem Description
The customer contacted stryker to report that their device did not charge when they attempted to provide defibrillation to the patient.In this state the device may not be able to provide defibrillation therapy if it were needed.This issue is patient related; however there was no adverse patient outcome reported.

• 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: 18667732
• Report Number: 0003015876-2024-00297
• Device Sequence Number: 15271794
• Product Code: MKJ
• UDI-Device Identifier: 00883873813829
• UDI-Public: 00883873813829
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 07/01/2024

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: 99507-000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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