MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC LIGHTSPEED; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problems Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2018

Event Type  malfunction  

Event Description

The patient was moved onto the table with the slide board and the extension to the table.He was moved down toward the extension with their body weight not centered onto the body of the table.With the patient moving, coupled with the body weight not distributed proportionately, the patient and slide board descended to the floor.The staff assisted and the patient was gradually lowered to the floor while remaining on the sheet and slide board.A new extension to the table was ordered.

• Brand Name: LIGHTSPEED
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 7544179
• MDR Text Key: 109254043
• Report Number: 7544179
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: YES, THE PATIENT HAD A SLIDE BOARD UNDERNEATH
• Patient Age: 82 YR
• Patient Weight: 82