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

Model Number CRPLUS

Device Problems Invalid Sensing (2293); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

The customer reported to physio-control service that their device showed a service wrench icon in the readiness display.During evaluation, it was observed that the device would continuously detect motion and would therefore not be able to charge and shock defibrillation energy when required.Several event codes had been logged into the device's memory.There was no patient use associated with the reported event.

Manufacturer Narrative

(b)(4).Physio-control evaluated the device and verified the reported failure.It was observed that the device displayed the service wrench and charge-pak icons and that the device had logged several event codes into the memory log.The device would continue to detect motion and could therefore not charge and defibrillation energy.Due to the device being out of its warranty period, the customer opted to not release the device for further evaluation, but to request the device to be returned unrepaired.

• Brand Name: LIFEPAK CR(R) PLUS DEFIBRILLATOR
• Type of Device: DEFIBRILLATORS, AUTOMATIC, EXTERNAL
• Manufacturer (Section D): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer (Section G): PHYSIO-CONTROL, INC; 11811 willows road ne; po box 97006; redmond WA 98073 970
• Manufacturer Contact: jason march ; 4258674000
• MDR Report Key: 3880177
• MDR Text Key: 4590531
• Report Number: 3015876-2014-00669
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/21/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 3200731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: No
• Device Age: 8 YR
• Event Location: Street
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2006
• 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