MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 1000 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	1000
Medical Device Problem Codes	Failure to Deliver Shock/Stimulation (1133); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device failed to provide defibrillation therapy during intervention on a patient.This issue is patient related; however there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.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 failed to provide defibrillation therapy during intervention on a patient.This issue is patient related; however, there was no adverse patient outcome reported.
Additional Manufacturer Narrative
A stryker service representative performed an initial evaluation of the customer¿s device and was able to verify and duplicate the reported issue.The technician visually inspected the device and noted that the quick-combo electrodes used in the reported event had physical damage- the cabling near the therapy connector was severely kinked, resulting in exposed internal wiring.This may have contributed to the device¿s failure to register the connection of the electrodes during the reported event.The technician then evaluated the functionality of the device¿s connection to multiple test leads and found that despite using leads that were known to be operational, they also failed to register with the device.Stryker further evaluated the customer¿s device at the product analyses center (pac) and the failure was verified.Technician observed that connectors j502 and 503 of analog pcb assembly were bent on board.By probing of connectors, the plastic body of connector j503 broken from board was found.After the cap was discharged entirely and bent both connectors straight again and reseated both ecg and therapy connectors, the return of full normal operation of the device was observed.The customer's device was archived by stryker.The customer has been provided with replacement device.The cause of the reported issue was determined to be due to damaged ecg and therapy connectors.

• Brand Name: LIFEPAK(R) 1000 DEFIBRILLATOR
• 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: 19151540
• Report Number: 0003015876-2024-01086
• Device Sequence Number: 9383710
• Product Code: MKJ
• UDI-Device Identifier: 00883873815465
• UDI-Public: 00883873815465
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White