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

Model Number	CR PLUS
Medical Device Problem Codes	Failure to Power Up (1476); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will receive a replacement device.Stryker performed an initial evaluation of the customer's device and the reported issue was able to be verified and able to be duplicated.Stryker found that the device's internal battery was depleted.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 their device was showing all 3 icons (charge-pak, attention and wrench) and it would not power on.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The customer's device was retuned to stryker product analysis center (pac) for further investigation.During pac investigation, the reported issue was able to be verified.The unit was able to power on using a good charge-pak.The root cause of the reported issue was determined to be a depleted charge-pak, resulting in a depleted internal battery (hlc).The customer's device was archived by stryker and the customer was provided with a replacement device.
Event or Problem Description
The customer contacted stryker to report that their device was showing all 3 icons (charge-pak, attention and wrench) and it would not power on.As a result, defibrillation would not be available, if needed.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) CR PLUS 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: 20031951
• Report Number: 0003015876-2024-02439
• Device Sequence Number: 16902933
• Product Code: MKJ
• UDI-Device Identifier: 00883873820568
• UDI-Public: 00883873820568
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160012
• 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): 01/31/2025

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: CR PLUS
• Device Catalogue Number: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2018
• 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 Sex: Unknown