MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC PRECISION 500D; SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE

Model Number 2403791

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare¿s investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Patient identifier and age currently unavailable.Device evaluation anticipated, but not yet begun.

Event Description

The customer reported the precision 500d system retractable step detached.Reportedly, the step detached as a patient stepped onto it causing the patient to fall forward into the table.The patient caught himself before falling further.There was no patient injury.

Manufacturer Narrative

Based on information from the hospital biomedical engineer, ge healthcare¿s investigation has concluded the holding nut backed out on the patient step left side causing the patient foot step to partially detach from the table.Since the issue was corrected by the hospital¿s biomedical engineer by re-tightening the holding nut, no parts were available for evaluation and no additional information was provided by the user.Therefore, the root cause for nut loosening could not be determined.

• Brand Name: PRECISION 500D
• Type of Device: SYSTEM, X-RAY, FLOUROSCOPIC, IMAGE
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha WI 53188
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076
• MDR Report Key: 5161660
• MDR Text Key: 28744727
• Report Number: 2126677-2015-00024
• 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
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2403791
• Other Device ID Number: 409883P500D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• 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 Weight: 95