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	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that their device is not field serviceable and no longer under warranty.Physio-control recommended that the device be permanently removed from service and that a replacement unit be obtained.The customer advised that they will send their device to physio-control for evaluation and eventual disposal.Physio-control 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 physio-control to report that their device had all three icons (charge pak, attention and service wrench) present on its readiness display and would not power on when prompted.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device had all three icons (charge pak, attention and service wrench) present on its readiness display and would not power on when prompted.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
The customer has not returned their device to physio-control for evaluation.As a result, the cause of the reported issue could not be determined.Device not evaluated by manufacturer.

• 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
• MDR Report Key: 8329912
• Report Number: 0003015876-2019-00240
• Device Sequence Number: 19267453
• Product Code: MKJ
• UDI-Device Identifier: 00883873820599
• UDI-Public: 00883873820599
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: Other
• Device Model Number: CRPLUS
• Device Catalogue Number: 97403-000006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1