MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC LEGACY DIGITAL R&F; TABLE, RADIOGRAPHIC, TILTING

Model Number XRF107

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported the legacy fluoroscopic table pulled out of the floor during angulation.Reportedly, the table was being tilted down when one side of the floor plate pulled out of the floor resulting in the table impacting the side wall on the head-end side.There was no patient involvement or operator impact.

Manufacturer Narrative

Ge healthcare¿s investigation has concluded that the root cause of this event was due to the user angulating the table onto a stool and using the incorrect size anchors during re-installation.No further details could be obtained as to why the incorrect anchors were used because the third party responsible for the re-installation is no longer in business.

• Brand Name: LEGACY DIGITAL R&F
• Type of Device: TABLE, RADIOGRAPHIC, TILTING
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076
• MDR Report Key: 5139971
• MDR Text Key: 27906337
• Report Number: 2126677-2015-00023
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• PMA/PMN Number: K973039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRF107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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