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	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the on/off lid latch had come off of the mounting bar and was resting between the bar and the rubber portion of the case.Also, the rubber bumper was missing from the latch that presses on the on/off button dome.Physio determined that the cause of the reported issue was that the rubber bumper that presses the on/off button dome was missing.As a result the device could not be powered on in order to charge and shock.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device's lid would not close properly and open by itself.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it would not power on when prompted.As a result, defibrillation would not be possible if it were necessary.
Event or Problem Description
The customer contacted physio-control to report that their device's lid would not close properly and open by itself.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it would not power on when prompted.As a result, defibrillation would not be possible if it were necessary.
Additional Manufacturer Narrative
Device identifier (di) number ¿ (b)(4).

• 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: 7423530
• Report Number: 0003015876-2018-00575
• Device Sequence Number: 10784123
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/07/2020

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: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1