MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRESTIGE SI; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/16/2015

Event Type  Injury  

Event Description

It was reported that while a patient was being assisted onto the table of a prestige si x-ray system for an intravenous pyelogram exam, the patient accidentally pressed the button which opens the drawer of the spot film device.When the drawer ejected, the patient was startled and lost their balance.As the patient fell to the floor, the technologist slowed the patients fall but the patient did fall onto a patient step that was on the exam room floor.The patient received several fractured ribs as a result of the impact with the patient step.

Manufacturer Narrative

(b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Manufacturer Narrative

Ge healthcare's investigation is completed.The root cause was determined to be use error.The user had laterally positioned the table towards the back side of the system.This enabled the patient to have access to the cassette drawer for support while getting onto the table.The patient accidentally pressed the cassette drawer eject button, causing the cassette drawer to open.Positioning the table laterally toward the front of the system would have limited the patient's access to the cassette drawer eject button.Ge healthcare communicated to the customer that before assisting patients getting on and off the table, the table should be laterally positioned toward the front of the system.No further actions are planned at this time.

• Brand Name: PRESTIGE SI
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3000 n.grandview blvd.; w450; waukesha WI 53188
• Manufacturer Contact: paul corrigan ; 3000 n.grandview blvd.; w450; waukesha, WI 53188 ; 4142130021
• MDR Report Key: 4613312
• MDR Text Key: 15247719
• Report Number: 2126677-2015-00005
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K943805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 92