MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 ASSY-LPCR PLUS,AUTO,ENGLISH,AHA2005; AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE)

Model Number	CR PLUS
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and found process residue on component c156 on the analog pcb.The process residue had caused an electrical short which led to both the customer's complaint and the critical error code.The customer's device was destructively tested, and the customer received a replacement device.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.There was no report of patient use associated with the reported event.Upon evaluation of the customer's device, physio-control observed that the device logged a critical error code that may result in defibrillation therapy being unavailable, if it is needed.

• Brand Name: ASSY-LPCR PLUS,AUTO,ENGLISH,AHA2005
• Common Device Name: AUTOMATIC EXTERNAL DEFIBRILLATOR (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9794046
• Report Number: 0003015876-2020-00330
• Device Sequence Number: 3332505
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: CR PLUS
• Device Catalogue Number: 99403-000157
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1