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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS BARIATRIC BED FOOT 9153641517
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INVACARE FLORIDA OPERATIONS BARIATRIC BED FOOT 9153641517 Back to Search Results
Model Number BAR600IVC
Device Problems Smoking (1585); Sparking (2595)
Patient Problem No Information (3190)
Event Date 07/30/2010
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.This product was part of an investigation into miskeying that is done at installation or service.The miskeying of the motor connector either at the crossover cable or the junction box results in a junction box failure.Miskeying places the ground connection from the motor onto one of the motor power pins.The hazards associated with miskeying are smoke inhalation or fire.
 
Event Description
When the dealer plugged the unit in, sparks allegedly spewed out of the motor and filled the room with smoke.
 
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Brand Name
BARIATRIC BED FOOT 9153641517
Type of Device
BARIATRIC BED
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5691411
MDR Text Key46289808
Report Number1031452-2016-02122
Device Sequence Number1
Product Code FNL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/30/2010
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBAR600IVC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2010
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/30/2010
Initial Date FDA Received06/01/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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