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 Patient Involvement (2645)
Date of Event	11/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that their device is no longer under warranty and not field serviceable.Physio-control recommended that the device be permanently removed from service and that a replacement device be obtained.The device has not been returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
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.The three icons being illuminated indicates that the device may not be able to provide sufficient defibrillation therapy, if necessary.The customer advised that they had obtained the device for possible use with a patient when the reported issue was observed; however, the device was not needed and was never connected to the patient for use.

• 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: 8133199
• Report Number: 0003015876-2018-02061
• Device Sequence Number: 1234011
• Product Code: MKJ
• UDI-Device Identifier: 00883873820674
• UDI-Public: 00883873820674
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 12/05/2018

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: 97403-000018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1