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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL
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INVACARE FLORIDA OPERATIONS CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number VC5310
Device Problems Collapse (1099); Unintended Head Motion (1284)
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
The tbm states the head springs have collapsed.The provider informed the tbm that the end user alleged the head section was sagging.The provider went out to check the bed and states the head springs had collapsed.
 
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Brand Name
CS3 BED 9153651161
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 Key5418615
MDR Text Key37726934
Report Number1031452-2016-00428
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
Remedial Action Replace
Type of Report Initial
Report Date 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberVC5310
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2016
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
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