MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® 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	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that their device is not field-serviceable and is no longer under warranty.Physio recommended that the customer remove the device from service and a replacement device be obtained.The device has not been returned to physio-control for an evaluation.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device does not power on when they press the on/off button and they don't hear any voice prompts from the device.The latch that holds the device's lid closed also appears to be broken and does not keep the lid closed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device does not power on when they press the on/off button and they don't hear any voice prompts from the device.The latch that holds the device's lid closed also appears to be broken and does not keep the lid closed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
Section e4 initial report sent to fda of the initial medwatch report should indicate: no.

• 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
• MDR Report Key: 8382425
• Report Number: 0003015876-2019-00352
• Device Sequence Number: 10840885
• Product Code: MKJ
• UDI-Device Identifier: 00883873820254
• UDI-Public: 00883873820254
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 99403-000004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1