MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 6800; FLUOROSCOPIC X-RAY

Model Number 6800

Device Problem Device Stops Intermittently (1599)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

A ge service rep performed an onsite investigation.The power supply needs to be replaced.The customer canceled the service call.

Event Description

The customer reported that the system locked up.There was no pt injury or death reported.

Manufacturer Narrative

The investigation into the reported event determined that there was no device malfunction.This is not a reportable event.

• Brand Name: 6800
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 5008755
• MDR Text Key: 23514978
• Report Number: 1720753-2015-03247
• Device Sequence Number: 1
• Product Code: JAA
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/13/2015

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: Health Professional
• Device Model Number: 6800
• Device Lot Number: 86-1569
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2005
• 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