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	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/25/2018
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 a capacitor, designator c157 (leg 3), on the analog pcb assembly had process residue which in turn shorted bias2 and bias voltages to 0.2 volts.This resulted in the ecg preamp behaving as though a patient load was connected when it was not, and prevented the device from detecting a patient load when it was properly connected.The customer was provided with a replacement device.
Event or Problem Description
The customer contacted physio-control to report that their device had a service wrench present on its readiness indicator.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that it would behave as though a patient load was being detected when no test load was actually connected.Additionally, when a proper test load was connected to the device it would incorrectly advise that the leads were off.Based on this behavior, physio-control determined that the device is incapable of properly detecting a patient load and therefore would be unable to charge and shock if it were 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: 7672236
• Report Number: 0003015876-2018-01068
• Device Sequence Number: 16373787
• Product Code: MKJ
• UDI-Device Identifier: 00885074440323
• UDI-Public: 00885074440323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/09/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1