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

Model Number	1000
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the device's display is blank.As a result, the labeling for both the analyze and charge soft key buttons at the bottom of the display would not be visible to the device user.This issue has the potential to delay or prevent defibrillation from being delivered.
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer's device and verified the reported issue.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 a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, stryker observed that the device's display is blank.As a result, the labeling for both the analyze and charge soft key buttons at the bottom of the display would not be visible to the device user.This issue has the potential to delay or prevent defibrillation from being delivered.
Additional Manufacturer Narrative
Stryker determined that the cause of the reported issue was due to a failed digital pcb assembly.The device was archived by stryker.

• Brand Name: LIFEPAK 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: dara friedman ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16443752
• Report Number: 0003015876-2023-00366
• Device Sequence Number: 5844812
• Product Code: MKJ
• UDI-Device Identifier: 00883873815465
• UDI-Public: 00883873815465
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122600
• 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): 06/29/2023

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: Lay User/Patient
• Device Model Number: 1000
• Device Catalogue Number: 99425-000025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2017
• 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