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 Charge (1085); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio observed that the device can not recognize a shockable patient rhythm to deliver defibrillation energy and does not recognize a patient connection had been made.Physio removed the analog pcb assembly for further evaluation.The cause of the reported issue was determined to be due to capacitor, designator c157.C157, leg 3 to leg 2, is electrically shorted from process residue and caused the device to not be able to charge and shock.The customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device related to the service wrench appearing on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that their device would not charge and shock.As a result, defibrillation energy would not be delivered, if it were necessary.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device related to the service wrench appearing on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that their device would not charge and shock.As a result, defibrillation energy would not be delivered, if it were necessary.
Additional Manufacturer Narrative
Gtin/device identifier (di) number ¿ (b)(4).

• 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: 7455563
• Report Number: 0003015876-2018-00650
• Device Sequence Number: 806653
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/21/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1