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 Deliver Shock/Stimulation (1133); Electrical /Electronic Property Problem (1198); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.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
A customer contacted stryker to report that their device did not provide shock to the patient and had logged an event code which is associated with a device lock up condition.As a result, defibrillation therapy would not be available, if needed.Additionally, it was reported that the customer later attempted to perform an output test, and it was observed that the defibrillation energy level was not as expected.There were no reports of adverse effects to the patient as a result of the reported event.
Event or Problem Description
A customer contacted stryker to report that their device did not provide shock to the patient and had logged an event code which is associated with a device lock up condition.As a result, defibrillation therapy would not be available, if needed.Additionally, it was reported that the customer later attempted to perform an output test, and it was observed that the defibrillation energy level was not as expected.There were no reports of adverse effects to the patient as a result of the reported event.
Additional Manufacturer Narrative
A stryker field service representative evaluated the customer's device and verified the reported issue of the event code.The cause of the reported issue was determined to be due to a faulty user interface pcb and system controller pcb.The reported issue of defibrillation energy delivery level could not be duplicated or verified.After performing other unrelated repairs, proper device operation was observed through functional or performance testing.The device was subsequently returned to the customer for use.

• 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: 18107262
• Report Number: 0003015876-2023-02073
• Device Sequence Number: 15382953
• Product Code: MKJ
• UDI-Device Identifier: 00883873813805
• UDI-Public: 00883873813805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/20/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2011
• 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