MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) 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	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Stryker advised the customer to remove their device from service and to replace due to age and end of life of product.The device was returned to the customer for use.The device was not returned to stryker for evaluation.Device not evaluated by manufacturer.
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
Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2022-01004) indicates: additional mfg narrative type ¿ stryker advised the customer to remove their device from service and to replace due to age and end of life of product.The device was returned to the customer for use.The device was not returned to stryker for evaluation.Section h10 and/or h11 of the initial medwatch report (mfr report #0003015876-2022-01004) should indicate: additional mfg narrative type ¿ stryker advised the customer to remove their device from service and to replace due to age and end of life of product.The device was not returned to stryker for evaluation.Additional information: since the device was not returned to stryker for evaluation, the root cause could not be determined.However, it is likely due to end-of-life as the device was manufactured in 2002.
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.

• Brand Name: LIFEPAK CR(R) 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: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 14677073
• Report Number: 0003015876-2022-01004
• Device Sequence Number: 4635476
• Product Code: MKJ
• UDI-Device Identifier: 00883873820278
• UDI-Public: 00883873820278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• 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): 08/03/2022

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: 99403-000006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2002
• 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