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

Model Number	CRPLUS
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer¿s device and verified the reported issue.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 displayed all three icons (charge-pak, attention, and service wrench).The illumination of all three icons indicates that the device may not be able to provide sufficient defibrillation therapy, if necessary.There was no patient use associated with this event.
Event or Problem Description
The customer contacted stryker to report that their device displayed all three icons (charge-pak, attention, and service wrench).The illumination of all three icons indicates that the device may not be able to provide sufficient defibrillation therapy, if necessary.There was no patient use associated with this event.
Additional Manufacturer Narrative
Stryker replaced the charge-pak and electrodes to resolve the reported issue.After observing proper device operation through function and performance testing, the device was returned to the customer for use.The cause of the charge-pak symbol was due to a failed charge-pak.The cause of the attention and service wrench icons were due to a logged event code in the device memory.

• Brand Name: LIFEPAK® 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: 18365896
• Report Number: 0003015876-2023-02430
• Device Sequence Number: 7856622
• Product Code: MKJ
• UDI-Device Identifier: 00883873820551
• UDI-Public: 00883873820551
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P160012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: CRPLUS
• Device Catalogue Number: 99403-000156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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