MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC COMPAX 40E; SYSTEM, X-RAY, STATIONARY

Model Number XRA505

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2017, the technologist at (b)(4) center in the usa reported that as they were positioning the tube away from the table after an exam with no patient on the table, the collimator detached from the tube head.The collimator fell and struck the edge of the table.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare's investigation has been completed.The root cause for the collimator detachment could not be identified but the most likely root cause is the 3rd party service team did not apply the appropriate torque during a previous service event.The ge field engineer (fe) arrived at the site and identified the collimator detached from the tube due to loosening of the set screws.The fe confirmed there was no broken or damaged mounting components in addition to confirming there was loctite residue on the set screws.The fe corrected the site by re-installing the collimator¿s set screws using loctite and applying the appropriate torque.Attempts were made to obtain the historical service records completed by the 3rd party service team but all attempts were unsuccessful.No further actions are needed.

• Brand Name: COMPAX 40E
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6451218
• MDR Text Key: 71583034
• Report Number: 2126677-2017-00004
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813173
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRA505
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• 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: N
• Patient Sequence Number: 1