MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR® PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	CRPLUS
Medical Device Problem Codes	Failure to Power Up (1476); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
Event or Problem Description
A customer contacted physio-control to report that their device was showing all three icons (attention, charge-pak and service wrench) and will not power on.With all three icons illuminated, the device may not have sufficient power available to deliver effective defibrillation therapy to a patient, if it was needed.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.It was observed that the device was unable to power on and the internal hybrid layer capacitor (hlc) batteries measured low voltage.Physio also observed evidence that a shorting plug was previously inserted into installed charge-pak battery.The shorting plug is used to safely deplete a charge-pak.When the depleted charge-pak was inserted into the device, the charge-pak rapidly depleted the hlc batteries.Physio determined that the cause of the reported issue was due to user error.The customer received a replacement device.
Event or Problem Description
A customer contacted physio-control to report that their device was showing all three icons (attention, charge-pak and service wrench) and will not power on.With all three icons illuminated, the device may not have sufficient power available to deliver effective defibrillation therapy to a patient, if it was needed.There was no patient use associated with the reported event.

• 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: 7630977
• Report Number: 0003015876-2018-00997
• Device Sequence Number: 1432905
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/16/2018

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: 99403-000156
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1