FORMASPLINT PB 105 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-13 for FORMASPLINT PB 105 * manufactured by Thermo-electric Co..

Event Text Entries

[299819] Drain heater coil overheated, resulting in production of smoking within unit. Visual check shows evidence of fire or burns. Operator notified fire department at time of incident. Fire department instructed to bring for inspection. Design flaw evident, as conditions has high likelihood of recurrence even after repair. Unit assembled with fiberglass insulation in contact with drain heater assembly and then covered. Suggest manufacturer re-design drain heater to isolate heating element from any flammable materials. Also, a timer should be placed in circuit to prevent power from being applied for an extended time to drain heater. Strongly recommend manufacturer design circuit breaker or fuse into unit to interrupt power in case of malfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1027003
MDR Report Key	433601
Date Received	2002-12-13
Date of Report	2002-12-13
Date Added to Maude	2002-12-23
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	FORMASPLINT
Generic Name	BATH, PARAFFIN
Product Code	IMC
Date Received	2002-12-13
Model Number	PB 105
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	N
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	422544
Manufacturer	THERMO-ELECTRIC CO.
Manufacturer Address	455 ROUTE 30 IMPERIAL PA 15126 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-12-13