MAUDE Adverse Event Report: GEHC MEDICAL SYSTEMS, LLC CT 750HD; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number CSPH49

Device Problem Unstable (1667)

Patient Problem Bruise/Contusion (1754)

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

Udi : (b)(4).Legal manufacturer: hcs beijing - west area of building no.3, no.1 yongchang north road, beijing economic and technological development area china beijing beijing, 100176.Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.

Event Description

It was reported that during ct servicing, the tube hoist malfunctioned; allowing the tube to fall and contact the fe; who sustained leg and foot bruising.

Manufacturer Narrative

Fe was using a manual hoist to remove a 250pound ct tube.The hoist broke and the tube fell onto his leg, shin and foot.He sustained a left thigh bruise, left shin abrasions and left foot bruising and swelling.The other fe replaced the tube.Root cause: hardware was loose or missing that holds the hoist assembly together.

• Brand Name: CT 750HD
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): GEHC MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GEHC MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: susan strasser ; 3000 n grandview blvd; waukesha, WI 53188
• MDR Report Key: 17258891
• MDR Text Key: 318843882
• Report Number: 2126677-2023-00004
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CSPH49
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• 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
• Patient Sex: Male