MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE SI; SYSTEM, X-RAY, FLUORO, IMAGE-INTENS

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.

Event Description

On (b)(6) 2022, the customer at (b)(6) center located in (b)(6) reported that the collimator on their prestige si remote fluoroscopy system detached and dropped from the vertical tube support.When the collimator detached, it did not impact any person and therefore there was no injury associated with this event.

Manufacturer Narrative

The cause of the collimator detaching was determined to be a user error.The ge field engineer (fe) went to the site and inspected the system and observed the four collimator mounting screws were damaged as all four screws had stripped threading.The technologist then informed the fe that the damaged mounting screws were caused by an accidental impact of the collimator into a foreign object.The technologist added that during the patient exam, they accidentally angulated the tube/collimator into a trolley and the collimator detached soon after.To correct the issue, the ge fe reinstalled the collimator using new collimator mounting screws.The customer was also reminded to inspect the surrounding area and ensure it is clear of all foreign objects before activating any commanded motorized movement of the system as outlined in the systems operator manual.No further actions are needed.

• Brand Name: PRESTIGE SI
• Type of Device: SYSTEM, X-RAY, FLUORO, IMAGE-INTENS
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188-1696
• MDR Report Key: 13451176
• MDR Text Key: 287579989
• Report Number: 2126677-2022-00005
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1