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

Model Number	1000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device would not detect batteries when inserted.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 the device would not detect batteries when inserted and would not power on.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
Stryker evaluated the customer's device and was able to verify the reported issue.The root cause of the reported issue was due to depleted batteries, which was most likely caused by installation of the accompanied battery discharge tools.The device was destructively tested.The customer received a replacement battery.

• 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 16337799
• Report Number: 0003015876-2023-00237
• Device Sequence Number: 6873628
• Product Code: MKJ
• UDI-Device Identifier: 00883873919477
• UDI-Public: 00883873919477
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/11/2023

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: 99425-000032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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