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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 09/06/2016

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.

Event Description

On (b)(6) 2016, the technologist at the hospital of (b)(6) reported that upon completion of a patient exam, and as they were positioning the monitor to the stored parked position on their prestige vh monitor suspension, the crt monitor detached and fell toward the ground.The monitor did not impact any person and therefore there was 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 all four of the support feet were crumbled.Upon investigation, it was determined the feet have been installed for approximately 20 years and therefore aged beyond their intended design life.The site was corrected by replacement of the monitor and 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 VH
• Type of Device: PRESTIGE REMOTE R & F SYSTEM MODELS
• 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: steven walczak ; 3000 north grandview blvd.; waukesha, WI 53188-1696
• MDR Report Key: 6000957
• MDR Text Key: 56507139
• Report Number: 2126677-2016-00014
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• 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