MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 600FP; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Device Problems Misassembled (1398); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

Ge healthcares investigation into the reported event has been initiated and is ongoing.A follow-up report will be submitted when the investigation has been completed.

Event Description

On (b)(6) 2020, the customer at (b)(6) in (b)(6) reported that as they were positioning the overhead tube suspension (ots) prior to a patient examination using their precision 600fp system, one of the ots bridges detached from the ots longitudinal railing causing the ots assembly to drop four to five inches.The other ots bridge was still attached to the longitudinal railing.There was no injury related to this event.The precision 600pf system is manufactured by (b)(4) and is distributed by (b)(4).

Manufacturer Narrative

Ge healthcare's investigation has been completed and the root cause of the issue was the improper tightening of the rubber stopper and the steel band retainers on the longitudinal rails that occurred during the installation of the overhead tube suspension (ots).This improper installation led to the steel roller coming off the rail and the partial detachment of the ots.To correct this issue, the ots was lifted and put back in place on the longitudinal railing.The rail stops and auxiliary stoppers were then re-installed, and the mounting bolts were torqued to specification.

• Brand Name: PRECISION 600FP
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10403478
• MDR Text Key: 204924601
• Report Number: 2126677-2020-00005
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K133553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1