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	Electrical /Electronic Property Problem (1198); Failure to Analyze Signal (1539); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed excessive noise on paddles ecg channel.In this state the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and observed excessive noise on paddles ecg channel.After replacing system pcb assembly, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Stryker further evaluated the replaced part at the product analyses center (pac) and the technician also observed the inability of the device to perform aed functions, worked in manual mode.The cause of the observed issues was determined to be due to electrically damaged ic chip u64 on the system pcb assembly.
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.During evaluation stryker observed excessive noise on paddles ecg channel.In this state the device may not be able to provide defibrillation therapy, if it were needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Section h6 device code grid of initial mdr indicates: output problem; electrical/electronic property problem.Section h6 device code grid of initial mdr should indicate: output problem; electrical/electronic property problem; failure to analyze signal.

• 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: 19346945
• Report Number: 0003015876-2024-01627
• Device Sequence Number: 6614211
• Product Code: MKJ
• UDI-Device Identifier: 00883873813805
• UDI-Public: 00883873813805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/15/2024

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: 99507-000010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2009
• 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