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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL
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INVACARE FLORIDA OPERATIONS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number VC5310
Device Problems Bent (1059); Break (1069); Collapse (1099)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Product has not been returned for evaluation as of the date of this investigation.Rma was issued.If new information becomes available at a later date, this complaint will be updated &/or a follow up be sent.
 
Event Description
Provider states the drive shaft broke while the patient was using the bed therefore the head section collapsed down with the patient laying on it, no injury.Provider states where the drive shaft connects on the head section of the bed is bent after this incident.
 
Manufacturer Narrative
Product was returned for evaluation.The return fields in oracle state: beds, mattresses, rails.Frame/structure.Frame/weld broken.Weld broke and metal tore on drive arm.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the broken weld on the head section.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
 
Event Description
Provider states the drive shaft broke while the patient was using the bed therefore the head section collapsed down with the patient laying on it, no injury.Provider states where the drive shaft connects on the head section of the bed is bent after this incident.
 
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Brand Name
SEMI ELECTRIC FOOT SPRING 9153638202
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 Key5597276
MDR Text Key44065684
Report Number1031452-2016-01657
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,Followup
Report Date 06/21/2016
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 NumberVC5310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/07/2016
Initial Date FDA Received04/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/27/2016
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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