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

Device Problems Device Slipped (1584); Installation-Related Problem (2965)

Patient Problems Pain (1994); Injury (2348); Muscle/Tendon Damage (4532)

Event Date 08/05/2020

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.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2020, the customer at (b)(6) reported that as the technologist was moving the monitor suspension with dual 19 inch lcd monitors to the left side of the room, it came off the monitor suspension railings on the left side.The suspension did not fall to the floor as it was still attached on the right side of the suspension.This event occurred after completion of a patient exam.When the event occurred, the technologist felt pain in her left wrist, left arm, left shoulder, neck and lower back.No additional details regarding the injury were provided by the customer.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 event was determined to be due to an installation error.Through further investigation, it was determined there were inadequate instructions/procedures to mount the rubber stoppers and steel band retainers to the longitudinal rail which then allowed the rollers to partially come off the longitudinal railing.To correct this issue, both the rubber stopper and steel band retainer were reinstalled.Ge healthcare has also initiated a field action to address the potential installation error in the installed base.This field action was reported to the fda per 21 cfr part 806 under correction and removal number 2126677-12/22/20-014-c on 22-dec-2020.

• 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: 10474756
• MDR Text Key: 209181582
• Report Number: 2126677-2020-00006
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2126677-12/22/20-014-C
• Patient Sequence Number: 1