MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DEFINIUM 8000; STATIONARY X-RAY SYSTEM

Device Problems Component Falling (1105); Unintended Movement (3026)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation is ongoing.A follow-up report will be submitted upon completion of the ge healthcare investigation.Due to country specific privacy laws, patient information is unavailable.

Event Description

On (b)(6) 2018, the customer at (b)(6) hospitalier (b)(6) in (b)(6) reported that as they were moving the overhead tube support (ots) on their definium 8000 system from the wall stand to the table, when they reached approximately half way to the table, the ots suddenly dropped.The patient was seated at the head end of the table when the ots dropped and therefore were out of harm's way.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare¿s investigation has been completed and the root cause was determined to be material fatigue.The ge engineering team obtained the systems overhead tube suspension (ots) vertical movement log and calculated that during the customer reported event, the tube drifted slowly downward at a maximum speed of 0.5m/s and a maximum acceleration of 0.92 m/s^2.During drifting, the spring then completely broke and the safety mechanism engaged.Upon safety mechanism engagement, the tube and column stopped moving down and was locked in place.The ge field engineer (fe) corrected the site by replacing the failed counterpoise spring.The spring was requested to be sent back for further analysis by the supplier.The supplier investigation concluded the spring fractured 1.5 coils from the shaft hook.The spring surface hardness measured 47.7 hrc which is within specification.Furthermore, stereomicroscopy and higher magnification scanning electron microscopy (sem) were used to examine the spring which concluded the spring failed in fatigue with no apparent material or manufacturing defects.No further actions are needed.

• Brand Name: DEFINIUM 8000
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha WI 53188
• MDR Report Key: 7241902
• MDR Text Key: 99234007
• Report Number: 2126677-2018-00005
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K051967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1