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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC FL23SE; HOSPITAL BED
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UMANO MEDICAL INC FL23SE; HOSPITAL BED Back to Search Results
Model Number FL23SE
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 10/21/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device was evaluated by service technician of distributor and picture was sent to the manufacturer for analysis.Picture analysis demonstrated that the customer had modified the cord with a pvc pipe that did not allow the cord to flex freely when bed is lowered.
 
Event or Problem Description
It was reported that the bed controls of a fl23se hospital bed were not working.It was further observed that the power cord was torn.There was no patient involvement, no impact or adverse event.
 
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Brand Name
FL23SE
Common Device Name
HOSPITAL BED
Manufacturer (Section D)
UMANO MEDICAL INC
230 boulevard nilus-leclerc
l'islet, G0R 2 C0
CA  G0R 2C0
MDR Report Key9475443
Report Number3009591865-2019-00022
Device Sequence Number2258575
Product Code FNL
UDI-Device Identifier10670482000040
UDI-Public011067048200004011170410
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,user faci
Initial Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date (Section B) 12/16/2019
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
Operator of Device No Information
Device Model NumberFL23SE
Device Catalogue NumberFL23SE
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2019
Initial Report FDA Received Date12/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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