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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL
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INVACARE FLORIDA OPERATIONS CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 5410IVC
Device Problems Bent (1059); Device Slipped (1584); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
Event Description
Provider states the bed was raised up by patient and then just fell back down, provider went out to evaluate the bed and noticed the hitch pin is bent into the pull tube on the head section and will not come out.
 
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Brand Name
CS BED 9153650455
Type of Device
BED, AC-POWERED ADJUSTABLE HOSPITAL
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 Key5451361
MDR Text Key39133738
Report Number1031452-2016-00621
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 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number5410IVC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Weight79
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