MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC VRT TABLE W/INTEGRATING TUBE STAND/ELEV; SYSTEM, X-RAY, STATIONARY

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Fracture, Arm (2351)

Event Date 10/21/2014

Event Type  Injury  

Event Description

It was reported that during a foot exam with a patient standing on the x-ray table, the patient stumbled and fell to the floor.The patient received a broken arm as a result of the fall to the floor and was treated at the hospitals emergency room.

Manufacturer Narrative

Patient identifier could not be obtained after multiple attempts.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Additional manufacturer narrative: ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Ge healthcare's investigation concluded that the cause of the event was determined to be use error.The table is not designed for a patient to stand on the table.

• Brand Name: VRT TABLE W/INTEGRATING TUBE STAND/ELEV
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n. grandview boulevard; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n. grandview boulevard; waukesha WI 53188
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4892385
• MDR Text Key: 6536774
• Report Number: 2126677-2015-00011
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K813173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Type of Report: Initial
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 117