MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 500D; SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE

Device Problems Inadequate Service (1564); Unstable (1667); Detachment of Device or Device Component (2907); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Fall (1848); Sweating (2444); Abdominal Cramps (2543)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

On (b)(6) 2018, the radiographic technologist at (b)(6) in the united states reported that during a small bowel exam as the patient was getting off the precision 500d table, the patient step detached.As the patient step detached, the patient fell backwards back onto the table and was stabilized by the technologist.There was no injury related to this event.

Manufacturer Narrative

Ge healthcare's investigation has been completed and the root cause of the patient step detaching from the table was identified as a servicing error.The servicing activities performed on the precision 500d fluoroscopic system at (b)(6) general hospital are performed by the hospitals in-house service team.The ge field engineer (fe) inspected the device and determined the hospitals in-house service representative drilled out the welded patient step mounting bolts and replaced the bolts with bolts that are not intended to be used on the system.Ge requested additional information regarding the previously damaged patient step but the customer was not able to provide any additional information regarding this prior event.The modified mounting hardware applied by the in-house service team was determined to be inadequate which resulted in the patient step detaching from the table.To correct this issue, the ge fe replaced the lower table tub as well as the patient step per instructions within the service manual.The hospital's in-house service team was also reminded to always perform servicing according to the most current service manual revision.No further actions are needed at this time.

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha WI 53188
• MDR Report Key: 7241162
• MDR Text Key: 99243447
• Report Number: 2126677-2018-00003
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 70