* GW208

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-24 for * GW208 manufactured by Ideal Products, Inc..

Event Text Entries

[1121220] Ultrasound gel warmer shorted out and burned the bottles of gel to the warming plate. Smelled like burning rubber. The gel warmer (ideal products) had heated the gel product (parker laboratories) to a point where the gel bottles at the top were disfigured (they had expanded) so that the bottles could not be removed without dismantling (unit is held together by rivets which had to be drilled). Upon inspection of the internal components it was noted that on the right hand heating receptacle for the gel bottles the metal tape (used to hold the heating element to the cylinder) had come loose and as such the shielding had become overheated. The recommendation of the manufacturer in the operation of these units is that the warmer be turned off overnight and on the weekends as some gels and lotions tend to break down and separate when exposed to heat for extended periods of time. We discussed the unit with ideal and they told me that the unit is equipped with a thermoswitch (rated at 160 degrees) in case the unit overheated. There are no plans to return the device to the manufacturer. The only sign of heat damage was the wiring which was taped to the receptacles and at points that would be expected during normal operation.
Patient Sequence No: 1, Text Type: D, B5


[1325460] Ultrasound gel warmer shorted out and burned the bottles of gel to the warming plate. Smelled like burning rubber. The gel warmer (ideal products) had heated the gel product (parker laboratories) to a point where the gel bottles at the top were disfigured (they had expanded) so that the bottles could not be removed without dismantling (unit is held together by rivets which had to be drilled). Upon inspection of the internal components it was noted that on the right hand heating receptacle for the gel bottles the metal tape (used to hold the heating element to the cylinder) had come loose and as such the shielding had become overheated. The recommendation of the manufacturer in the operation of these units is that the warmer be turned off overnight and on the weekends as some gels and lotions tend to break down and separate when exposed to heat for extended periods of time. We discussed the unit with ideal and they told me that the unit is equipped with a thermoswitch (rated at 160 degrees) in case the unit overheated. There are no plans to return the device to the manufacturer. The only sign of heat damage was the wiring which was taped to the receptacles and at points that would be expected during normal operation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1515149
MDR Report Key1515149
Date Received2009-09-24
Date of Report2009-09-23
Date of Event2009-09-15
Report Date2009-09-23
Date Reported to FDA2009-09-24
Date Added to Maude2009-10-26
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 Sequence Number: 1

Brand Name*
Generic NameULTRASOUND GEL WARMER
Product CodeMUI
Date Received2009-09-24
Model NumberGW208
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age5 YR
Device Sequence No1
Device Event Key0
ManufacturerIDEAL PRODUCTS, INC.
Manufacturer Address1287 COUNTY ROAD 623 BROSELEY MO 63932712 US 63932 7129

Device Sequence Number: 2

Brand NameSCAN
Generic NameULTRASOUND GEL
Product CodeMUI
Date Received2009-09-24
Model NumberSCAN
Catalog Number*
Lot Number*
ID Number*
Device Sequence No2
Device Event Key0
ManufacturerPARKER LABORATORIES, INC.
Manufacturer Address286 ELDRIDGE ROAD FAIRFIELD NJ 07004 US 07004


Patients

Patient NumberTreatmentOutcomeDate
10 2009-09-24

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