MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC PRESTIGE SI; PRESTIGE REMOTE R & F SYSTEM MODELS

Model Number XRE512

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

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.No report of patient involvement.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2016, a technologist reported that while positioning the dual crt monitor suspension upon completion of a patient exam, one monitor detached and fell to the ground.There was no person or object impacted and therefore no injury related to this event.

Manufacturer Narrative

Ge healthcare¿s investigation has completed and the root cause was determined to be degradation of the monitor¿s support feet due to age.The ge field engineer arrived at the site and identified one of the support feet was crumbled.Upon investigation, it was determined the feet have been installed for approximately 18 years and therefore aged beyond their intended design life.The site was corrected by replacing the monitor support feet.This action was reported to fda per 21 cfr part 806 on 01-dec-2016.Ge healthcare has not yet received a corrections and removals report number regarding this action.

• Brand Name: PRESTIGE SI
• Type of Device: PRESTIGE REMOTE R & F SYSTEM MODELS
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI 53188
• Manufacturer (Section G): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI 53188
• Manufacturer Contact: steven walczak ; 3000 north grandview blvd.; waukesha, WI 53188-1696
• MDR Report Key: 5884700
• MDR Text Key: 53319677
• Report Number: 2126677-2016-00011
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K943805
• 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: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XRE512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: N
• Patient Sequence Number: 1