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

Model Number CRPLUS

Device Problem Invalid Sensing (2293)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.  physio determined that the cause of the reported issue was process residue at the capacitor, designator c157, on the analog pcb assembly.  the process residue at c157 shorted the bias 2 voltage to ground, causing the circuitry to respond by producing a flat line ecg trace and a continuously connected patient input that could not be shocked.The customer was provided with a replacement device.(b)(4).

Event Description

The customer contacted physio-control to report that their device had a service wrench icon present on its readiness display.  there was no patient use associated with the reported event.  upon evaluation of the customer's device, physio-control observed that it behaved as though a patient (test) load was always connected, and that the ecg waveform was always a flat line.  as a result, the device would not detect changes in the ecg waveform (i.E.A shockable rhythm) and would not be able to charge and shock if it were necessary.

• Brand Name: LIFEPAK CR(R) PLUS DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 4258674000
• MDR Report Key: 6909679
• MDR Text Key: 88002106
• Report Number: 3015876-2017-01223
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Device Age: 2 YR
• Event Location: School
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1