HI-LO MAT TABLE SIT/STAND ATTACHMENTS TG0801 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-10 for HI-LO MAT TABLE SIT/STAND ATTACHMENTS TG0801 * manufactured by Tri W-g, Inc..

Event Text Entries

[618129] A bariatric physical therapy mat table, manufactured by tri w-g, model number tg1957, was installed three months ago. This particular table is rated for patients weighing up to 1000 lbs. The sit-to-stand attachments were purchased as an accessory to the table from tri w-g as well. The attachments came with no instructions or specifications indicating the weight limit of the device. Per hospital policy, the attachments could not be installed until instructions were provided by the manufacturer. A call was placed to tri w-g, and they were responsive to our requests for instructions, and for specifications stating the weight limit of the attachments. However, they admitted that they did not have a specification stating the weight limit of the attachments specifically, so they agreed to load test the attachments. After load testing was completed, they sent a declaration that the attachments will only be rated for 500 lbs, and are making an official sticker for us to put on the device. In addition, even though they originally told us via phone that we could mount the attachments on any side of the table, they retracted that statement after testing, and said we are only to mount them on one certain side. We are concerned that the manufacturer did not perform adequate due diligence before marketing the attachments as an accessory. Also, their user manual needs to be updated to reflect installation instructions for the attachments and the weight limit. We have other tri w-g tables in the hospital and out-patient buildings, and are taking measures to ensure they have the correct specifications as well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number850428
MDR Report Key850428
Date Received2007-05-10
Date of Report2007-05-10
Date of Event2007-04-24
Report Date2007-05-10
Date Reported to FDA2007-05-10
Date Added to Maude2007-05-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHI-LO MAT TABLE SIT/STAND ATTACHMENTS
Generic NameATTACHMENT, BED, BARIATRIC
Product CodeJFB
Date Received2007-05-10
Model NumberTG0801
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age3 MO
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key837394
ManufacturerTRI W-G, INC.
Manufacturer Address215 12TH AVENUE NE VALLEY CITY ND 58072 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-05-10

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