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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC FREEDOM 500; MEDICAL BED
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UMANO MEDICAL INC FREEDOM 500; MEDICAL BED Back to Search Results
Model Number FM500
Device Problems Component Missing (2306); Out-Of-Box Failure (2311); Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Patient Involvement (2645)
Event Date 07/25/2016
Event Type  malfunction  
Event Description
It was alleged that a bed model fm500 was found with a support arm disassembled from a footend rail.The bed was not in service, the situation was noticed during inspection of bed.There were no reported adverse event.
 
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Brand Name
FREEDOM 500
Type of Device
MEDICAL BED
Manufacturer (Section D)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA  G0R 2C0
Manufacturer (Section G)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, quebec G0R 2 C0
CA   G0R 2C0
Manufacturer Contact
maude thibault
230 boulevard nilus-leclerc
l'islet, quebec G0R 2-C0
CA   G0R 2C0
MDR Report Key7133521
MDR Text Key95904730
Report Number3009591865-2017-00004
Device Sequence Number1
Product Code FNL
UDI-Device Identifier00670482000081
UDI-Public00670482000081
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 Other
Remedial Action Repair
Type of Report Initial
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFM500
Device Catalogue NumberFM500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2016
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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