FLUIDOTHERAPY UNIT 115 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-04 for FLUIDOTHERAPY UNIT 115 * manufactured by Henley Intl.

Event Text Entries

[63625] On 19 aug 1996, the fluidotherapy unit, in occupational therapy caught on fire. The henley int'l fluidotherapy unit is a therapy unit designed to blow cellex particles, a sand like material, over the pts hands which are inserted into gloves giving the pt the feeling of a "fluidized bed". Heaters, which are controlled by the operator, are incorporated into the therapy. The initial check out found that the power cord was not damaged and both the air and temperature fuses (15 amp) located on the control panel had not blown. The temperature setting for the heater was set on medium (113 degree - 117 degree f). After the control panel was removed, large quantities of cellex particles were discovered in the blower motors indicating that they had seeped into the plenum chamber. The mfr's literature indicates that air flows from the blower up through a foam distributor which is designed to stop the cellex particles from leaking into the plenum chamber. Upon disassembly of the unit, burn marks were found at the right glove and the bottom of the cellex chamber along the wood supports and perforated metal plates. When the foam distributor was investigated, it was found to be burnt and largely deteriorated. It appears that when parts of the foam distributor fell off and came in direct contact with heater they caught fire & were then blown around in the unit by the blower motor setting fire to right glove and wood supports. Admin research indicates that the unit had scheduled svs performed on it on 17 jun 1996. The medical maintenance technician who performed svs at that time found no deficiencies or indications of problems. It is the finding of this office that the fire was a unforeseen incident. Because the unit's rivets must be removed to get to foam distributor & the literature states that "fiberglass units should be returned to factory for heater replacement", the foam distributor could not be inspected during routine scheduled services.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4001890
MDR Report Key95924
Date Received1997-06-04
Date of Report1996-08-23
Date Added to Maude1997-06-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFLUIDOTHERAPY UNIT
Generic NameFLUIDOTHERAPY UNIT
Product CodeLSB
Date Received1997-06-04
Model Number115
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key94716
ManufacturerHENLEY INTL
Manufacturer Address104 INDUSTRIAL BLVD SUGARLAND TX 774783128 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-06-04

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