MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC COMPAX 40E

Model Number XRA003

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

It was reported that when the technologist was repositioning the tube of a compax 40e x-ray system after doing an ap upright view, the collimator detached and hit her on the wrist.A pt was on the table at the time but was not injured.There was no injury to the technologist as a result of the collimator impacting the wrist.

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

• Brand Name: COMPAX 40E
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer Contact: paul corrigan ; 3000 n grandview blvd.; w450; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4350569
• MDR Text Key: 15911218
• Report Number: 2126677-2014-00025
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K88493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRA003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/1993
• 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