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	Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control determined that the cause of the reported issue was that internal hybrid layer capacitor (hlc) battery, designator bt3, on the analog pcb assembly had a broken negative tab weld, leaving it open to the device circuit.This resulted in hlc battery bt3 depleting to zero, which could compromise the device's ability to charge and shock if it were necessary.The device did power on, charge and shock during testing.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device had displayed a premature low-battery indicator.There were no reports of patient use associated with the reported issue.Upon evaluation of the device, physio-control observed that the internal hybrid layer capacitor (hlc) batteries had depleted, which could inhibit the device's ability to provide defibrillation therapy, if necessary.

• 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: 7918616
• Report Number: 0003015876-2018-01604
• Device Sequence Number: 16622895
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/28/2018

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: 08/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1