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	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the device and verified the reported issue.Physio determined that the cause of the reported issue was due to the on/off lid latch missing from the device.This prohibited the device from being able to power on.The customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report that the switch on their device was damaged and was keeping the device's charge-pak from going in and out.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the on/off lid latch was missing and the device could not be powered on.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank.Section d4 of the initial medwatch report should indicate: device identifier (di) number ¿ (b)(4).
Event or Problem Description
The customer contacted physio-control to report that the switch on their device was damaged and was keeping the device's charge-pak from going in and out.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the on/off lid latch was missing and the device could not be powered on.

• 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: 7380522
• Report Number: 0003015876-2018-00517
• Device Sequence Number: 1051548
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/04/2020

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: 99403-000156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1