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

Model Number	20E
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker requested additional information on the patient from the customer.The customer informed stryker that no further patient information is available.Patient fields in which information was not provided were intentionally left blank.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 they were using their device on a patient and the device only delivered a shock of 79 joules at a selected energy level of 200 joules.There were no reports of any adverse effects to the patient as a result of the reported issue.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.Stryker replaced the device's therapy pcb assembly as a precaution.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that they were using their device on a patient and the device only delivered a shock of 79 joules at a selected energy level of 200 joules.There were no reports of any adverse effects to the patient as a result of the reported issue.

• 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: 19178646
• Report Number: 0003015876-2024-01240
• Device Sequence Number: 17992781
• Product Code: MKJ
• UDI-Device Identifier: 00883873813829
• UDI-Public: 00883873813829
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2024

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: 04/17/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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