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

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

It was reported that when the technologist was parking the tube for the night from a compax 40e x-ray system, they pressed the brake button to move the suspension, and the collimator suddenly detached from the overhead tube suspension.The collimator did hit the technologies wrist but did not result in a serious injury.

Manufacturer Narrative

Ge healthcare investigation is ongoing.A f/u report will be submitted once the investigation has been completed.

• Brand Name: COMPAX 40E
• Type of Device: SYSTEM, X-RAY, STATIONARY,
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; waukesha WI
• Manufacturer Contact: joy sonsalla ; 3000 n grandview blvd.; w450; waukesha, WI 53188 ; 2625482661
• MDR Report Key: 3902787
• MDR Text Key: 19087760
• Report Number: 2126677-2014-00007
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K813173
• 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
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/1994
• 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