MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE VH; FLUOROSCOPIC IMAGE INTENSIFIED

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Injury (2348)

Event Date 09/25/2014

Event Type  Injury  

Event Description

It was reported that while a ge healthcare field service engineer (gehc fe) was servicing a prestige vh system, as he was dismounting the gear motor tube arm brake with the table angled at about 60 degrees, when the brake was released, the whole tube arm assembly slid down.The tube arm assembly struck the field engineer on the head causing a laceration and also struck his wrist causing a fracture.

Manufacturer Narrative

Ge healthcare field engineer information was not provided.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

• Brand Name: PRESTIGE VH
• Type of Device: FLUOROSCOPIC IMAGE INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI
• Manufacturer Contact: paul corrigan ; 3000 n grandview blvd.; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4212984
• MDR Text Key: 19403474
• Report Number: 2126677-2014-00019
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/1997
• 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
• Patient Outcome(s): Other