MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFEPAK CR(R) PLUS DEFIBRILLATOR; DEFIBRILLATORS, AUTOMATIC, EXTERNAL

Model Number	CRPLUS
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After additional investigation, the cause of the reported issue was determined to be due to process residue on/around component c157 from the analog pcb assembly, that caused excessive leakage current.Process residue at this capacitor location can cause the ecg signal to be a flat line and the device would not be able to recognize a shockable ecg rhythm.
Event or Problem Description
The customer initially reported that their device was showing its service wrench.After further investigation into the reported issue, it was observed that there was an issue with the device that can cause the ecg signal to be a flat line and the device would not be able to recognize a shockable ecg rhythm as a result.There was no patient use associated.

• Brand Name: LIFEPAK CR(R) PLUS DEFIBRILLATOR
• Common Device Name: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 7762685
• Report Number: 3015876-2018-00107
• Device Sequence Number: 13901492
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2018

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: No Information
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1