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	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio determined the cause of the reported issue was due to a failure of integrated circuit, designator u16 on the digital pcb assembly.The integrated circuit, designator u16 is electrically shorted and caused excess off current and only 2.3 volts at leg 1 which depleted the hybrid layer capacitors (hlc's) and charge-pak.The customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device had two icons (charge pak and attention) present on its readiness display.There was no patient use associated with the reported issue.Upon evaluation of the customer¿s device, physio-control found that the device had all three icons (charge pak, attention and service wrench) present on its readiness display and the device would not power on.The three icons being illuminated indicates that the device may not be able to provide sufficient 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: 7696372
• Report Number: 0003015876-2018-01136
• Device Sequence Number: 19165013
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: 06/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1