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	08/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer received a replacement device.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
A customer contacted physio-control to report that their device was showing all three icons (attention, charge-pak and service wrench).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.Physio-control determined that the cause of the reported issue was that hybrid layer capacitor (hlc) batteries, designators bt1, bt2 and bt3, of the analog pcb would no longer hold a charge.The hlc batteries would no longer hold a charge because they were damaged after exposure to water inside the device that resulted in corrosion of the internal components.
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).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(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: 7827006
• Report Number: 0003015876-2018-01408
• Device Sequence Number: 16728605
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/02/2018

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: 08/14/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1