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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS QS820 MANUAL BED BED, MANUAL

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INVACARE FLORIDA OPERATIONS QS820 MANUAL BED BED, MANUAL Back to Search Results
Model Number IH820
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.
 
Event Description
The weld at the bottom of the leg frame has broke.
 
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review. Information updated to reflect the correct complaint awareness date, initial reporter, and device model number.
 
Event Description
The weld at the bottom of the leg frame has broken.
 
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Brand NameQS820 MANUAL BED
Type of DeviceBED, MANUAL
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 Key5679006
MDR Text Key45990805
Report Number1031452-2016-02362
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 11/21/2011
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIH820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2011
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

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