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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC. FLORENCE; AC POWER AJDUSTABLE MEDICAL BED
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UMANO MEDICAL INC. FLORENCE; AC POWER AJDUSTABLE MEDICAL BED Back to Search Results
Model Number FL23SE
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
The user did not return any parts of the bed to the manufacturer.After investigation, the most probable cause was a damaged caster by an impact to the bed.A caster stem needed replacement.The caster was replaced, the bed performs as expected.The manufacturer will follow the trend.
 
Event Description
The manufacturer was informed on december 7th, 2020, of an alleged reduced/inadequate brake force.No patient involvement.
 
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Brand Name
FLORENCE
Type of Device
AC POWER AJDUSTABLE MEDICAL BED
Manufacturer (Section D)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, G0R 2 C0
CA  G0R 2C0
Manufacturer (Section G)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, G0R 2 C0
CA   G0R 2C0
Manufacturer Contact
manon l. fraser
230 boulevard nilus-leclerc
l'islet, G0R 2-C0
CA   G0R 2C0
MDR Report Key11055122
MDR Text Key223763494
Report Number3009591865-2020-00027
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,foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial
Report Date 12/22/2020
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 No Information
Device Model NumberFL23SE
Device Catalogue NumberFL23SE
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2013
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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