MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC PRECISION 500D; SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE

Model Number XRF116

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2015

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.(b)(4): device evaluation anticipated, but not yet begun.

Event Description

The customer reported the precision 500d system monitor fell.Reportedly, the monitor fell to the floor when the technologist was moving the monitor boom forward so that the monitor could be seen better by the doctor.There was no patient or healthcare worker injury.

Manufacturer Narrative

Ge healthcare¿s investigation has completed and the cause of the monitor detaching from the monitor suspension was due to installation error as there was evidence not all of the mounting bolts were initially installed.The root cause of why the bolts were not installed could not be determined as the person responsible for installing the bolts is no longer employed with ge.No further actions are needed at this time.

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE
• 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
• MDR Report Key: 5193781
• MDR Text Key: 30017173
• Report Number: 2126677-2015-00026
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

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: XRF116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 11/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• 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
• Patient Weight: 79