Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC. FLORENCE; AC-POWERED ADJUSTABLE HOSPITAL BED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UMANO MEDICAL INC. FLORENCE; AC-POWERED ADJUSTABLE HOSPITAL 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
With regards to the brakes: 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 and the caster was replaced.With regards to the batteries: no adverse effect involving the beeping batteries.Battery pack also replaced.The bed performs as expected.The manufacturer will follow the trend.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLORENCE
Type of Device
AC-POWERED ADJUSTABLE HOSPITAL 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 Key11055127
MDR Text Key242173905
Report Number3009591865-2020-00028
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
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberFL23SE
Device Catalogue NumberFL23SE
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-