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

Model Number	20
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A third party service agent evaluated the customer's device and was able to verify the reported issue.It was observed that the issue is related to the faulty paddles.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.The faulty paddles will be further evaluated at the product assessment center (pac).
Event or Problem Description
The customer contacted stryker to report that their device did not provide defibrillation energy.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted stryker to report that that their device did not provide defibrillation energy.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The internal paddles handle assembly was returned to stryker for further investigation, where the reported issue has been verified.The root cause of the reported issue is determined to be isolated to the basic switch component.The internal paddles handle assembly was destructively tested.The customer received a warranty replacement.

• Brand Name: LIFEPAK® 20 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16493041
• Report Number: 0003015876-2023-00413
• Device Sequence Number: 17737797
• Product Code: MKJ
• UDI-Device Identifier: 00883873824702
• UDI-Public: 00883873824702
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 20
• Device Catalogue Number: 70402-000057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2003
• 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