WINCO 6Y48 6Y48-37

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-31 for WINCO 6Y48 6Y48-37 manufactured by Winco Mfg., Llc.

Event Text Entries

[131741663] Report mw5077640 was filed by facility claiming our recliner failed when patient tried to push himself up to get out of chair, side arm latch malfunctioned and side panel swung open unexpectedly, causing patient to fall on floor. Patient broke his hip and had to be transfered to another facility for hip surgery. Patient was unattended when event occurred. It was reported as model#6240 inverness 24-hour treatment recliner. It was in fact model #6y40 vero recliner. Initial e-mails indicated that a work order to repair the chair may have already been issued for the recliner prior to this alleged incident, and therefore should have been removed from service per user instructions. Facility also indicated that staff were not aware of the swing arm option and therefore proper operation on this recliner was not undestood, as they were given this recliner by a different department. Winco engineer traveled to facility to evaluate chair. He concluded, based on visible inspection, that the hinge was damaged (bent) by excessive weight being applied to open arm panel, contrary to user instructions. This most likely occurred before the incident and likely lead to the alleged malfunction. No damage to latch was evident, and it operated properly when tested. Winco was not given an incident report or allowed to have recliner returned to winco for complete evaluation. The facility was unable to give us any information on the outcome of the patients surgery or recovery. There is no physical evidence, visual evidence, or product history to indicate that the swing arm latch failed. Root cause is excessive weight being placed on opened swing arm, bending the hinge; improper training and improper maintenance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1027229-2018-00002
MDR Report Key8206762
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-12-31
Date of Report2018-12-31
Date of Event2018-05-08
Date Mfgr Received2018-05-10
Device Manufacturer Date2017-09-30
Date Added to Maude2018-12-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RANDAL LANDRY
Manufacturer Street5516 S.W. 1ST LANE
Manufacturer CityOCALA FL 34474
Manufacturer CountryUS
Manufacturer Postal34474
Manufacturer Phone3528542929
Manufacturer G1WINCO MFG., LLC
Manufacturer Street5516 S.W. 1ST LANE
Manufacturer CityOCALA FL 34474
Manufacturer CountryUS
Manufacturer Postal Code34474
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWINCO
Generic NameVERO RECLINER
Product CodeFRJ
Date Received2018-12-31
Model Number6Y48
Catalog Number6Y48-37
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWINCO MFG., LLC
Manufacturer Address5516 S.W. 1ST LANE OCALA FL 34474 US 34474


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-12-31

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