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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UMANO MEDICAL INC. OOK SNOW; HOSPITAL BED
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UMANO MEDICAL INC. OOK SNOW; HOSPITAL BED Back to Search Results
Model Number FL36
Medical Device Problem Code Communication or Transmission Problem (2896)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/03/2022
Type of Reportable Event Malfunction
Event or Problem Description
Technical service of the manufacturer was informed that the brake bed status of hospital bed works intermittently.There was no patient involvement.
 
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Brand Name
OOK SNOW
Common Device Name
HOSPITAL BED
Manufacturer (Section D)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, qc G0R 2 C0
CA  G0R 2C0
Manufacturer (Section G)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, qc G0R 2 C0
CA   G0R 2C0
Manufacturer Contact
saoussen gammoudi
230 boulevard nilus-leclerc
l'islet, qc G0R 2-C0
CA   G0R 2C0
MDR Report Key15898175
Report Number3009591865-2022-00031
Device Sequence Number17423928
Product Code FNL
UDI-Device Identifier00670482000500
UDI-Public010067048200050011220407
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/01/2022
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 Model NumberFL36
Device Catalogue NumberFL36
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/03/2022
Initial Report FDA Received Date12/01/2022
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured04/07/2022
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient SexUnknown
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