MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 500D R&F X-RAY SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number 2290800

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

A ge healthcare investigation has been initiated and is ongoing.A follow-up mdr will be provided when ge healthcare's investigation has been completed.Although requested, the user was unable to provide patient information.Although requested, the user was unable to provide the incident date.Device evaluation anticipated, but not yet begun.

Event Description

During a periodic maintenance inspection being performed on (b)(6) 2019 at riverside healthcare in the united states, the ge field engineer (fe) was notified that a patient had fallen off their precision 500d systemâ¿¿s table and was injured.The customer reported that during an exam while waiting for time to elapse to continue with the procedure, the patient had fallen asleep while lying on the table.While they were asleep, they fell from the table and received a broken toe.The customer did not provide any further details of the event.

Manufacturer Narrative

Ge healthcare's investigation has been completed and the root cause of the patient falling from the table is use error.The ge field engineer (fe) arrived at the customer site to investigate the event but did not identify any system malfunction and no corrections were made to the system.Investigation confirmed that as the user was waiting for time to elapse on a time sensitive exam with a patient on the table, the patient fell asleep and then accidently rolled off the table.The investigation concluded that standard care operating procedures involve applying the principles of patient safety during radiographic procedures, which includes assisting and transporting patients as needed.In addition, the system operatorâs manual cautions that it is the responsibility of the operator to ensure the safety of the patient at all times.When the table is in use, the patient should be monitored by visual observation, use of proper patient positioning, and use of the protective devices provided.As a correction, the radiology manager and staff were reminded to visually observe patients at all times, in addition to instructing how and when to use the compression band to support the patient on the table.No further actions are needed.

• Brand Name: PRECISION 500D R&F X-RAY SYSTEM
• 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: 8631846
• MDR Text Key: 145779682
• Report Number: 2126677-2019-00005
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2290800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention