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	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue.Physio-control also observed that the device would not power on when prompted.Physio-control found that the customer had previously installed the shorting plug (discharger) onto the device¿s charge pak assembly and then removed it.This action of installing and removing the shorting plug crushed the contacts on the charge pak assembly and upon being placed back into the device, caused its internal hybrid layer capacitor (hlc) batteries to deplete which prevented the device from powering on.The device's operating instructions advise the following: "do not attempt to remove the discharger once it is in place." no further discrepancies with the device were observed.The cause of the reported issue was determined to be use error due to the customer not following instructions by installing, then removing, the shorting plug onto the charge pak assembly prior to reinstalling it into the device which resulted in the depletion of the internal hlc batteries.The customer was provided with a replacement device.
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.

• 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: 7692550
• Report Number: 0003015876-2018-01123
• Device Sequence Number: 751977
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/31/2018

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: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1