MAUDE Adverse Event Report: ENTRAK 2500; RADIOLOGICAL IMAGE PROCESSING

Model Number ENTRAK 2500

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

The customer reported that the system failed to boot and exhibited a non-recoverable loss of functionality.No patient serious injury or death was reported related to this event.

Manufacturer Narrative

A ge service representative performed an over the phone investigation.System file corruption was identified as the cause of the event.The reported problem was resolved by the customer with assistance from the engineer.No additional service information was provided.

• Brand Name: ENTRAK 2500
• Type of Device: RADIOLOGICAL IMAGE PROCESSING
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 4890833
• MDR Text Key: 18995475
• Report Number: 1720753-2015-02631
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENTRAK 2500
• Device Lot Number: IT25047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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