MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR(R) PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	CRPLUS
Medical Device Problem Codes	Invalid Sensing (2293); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2018
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 c178, on the analog pcb assembly had process residue.The process residue made the voltages for legs 5, 6, and 7 of an integrated circuit (ic), designator u15, to not be the correct voltage values which kept the ecg waveform at a flat line.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 the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order to charge and shock, if it were necessary.
Additional Manufacturer Narrative
Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank section d4 of the initial medwatch report should indicate: device identifier (di) number ¿ (b)(4).
Event or Problem Description
The customer contacted physio-control to report that their device had a service wrench present on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order 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: 7400259
• Report Number: 0003015876-2018-00552
• Device Sequence Number: 11181902
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 02/07/2020

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: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1