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

Model Number XRF117

Device Problems Break (1069); Use of Device Problem (1670); Noise, Audible (3273); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2018

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.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2018, the doctor at (b)(6) in the united states reported that as they angulated the table of their precision 500d system to approximately forty-five degrees during a patient exam, they heard an audible noise described as a "grinding noise." as the doctor continued to attempt to angulate the table, they did not realize the table had impacted the overhead tube suspension (ots) which led to the gooseneck of the ots to break apart leading to detachment of the tube/collimator assembly.As the tube/collimator assembly fell, it struck the table railing and did not impact any person.There was no injury related to this event.

Manufacturer Narrative

Ge healthcareâs investigation has been completed and the root cause for the tube and gooseneck detachment was due to a use error.The overhead tube suspension (ots) gooseneck was returned for engineering analysis and there was no evidence of casting porosity or shrinkage and surface finishes and paint finish appeared normal.One small crack was identified which appears to be where the failure originated.In conclusion, the user angulated the table without noticing the ots was parked inappropriately in the path of table angulation.The user continued to angulate the table without realizing the impact which caused the breakage of the gooseneck.To correct this issue the field service engineer (fe) replaced the gooseneck.In addition, the fe also reminded the customer to park the ots away from table during any patient exam.No further actions are needed.

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulavard; waukesha, WI 53188
• MDR Report Key: 7898817
• MDR Text Key: 121714390
• Report Number: 2126677-2018-00017
• Device Sequence Number: 0
• Product Code: JAA
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRF117
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 64