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. OOK SNOW; 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. OOK SNOW; HOSPITAL BED Back to Search Results
Model Number FL36
Device Problems Sparking (2595); Battery Problem (2885); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2023
Event Type  malfunction  
Manufacturer Narrative
Note: (b)(6)2024 resubmitting report in production environment.Kindly see attachment.
 
Event Description
The customer reported to the technical service of the manufacturer that when they plugged the bed in their outlet it sparks, and smoke came out of the outlet , causing the facility breaker to trip.No adverse consequence were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OOK SNOW
Type of Device
HOSPITAL BED
Manufacturer (Section D)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, quebec G0R2C 0
CA  G0R2C0
Manufacturer (Section G)
UMANO MEDICAL INC.
230 boulevard nilus-leclerc
l'islet, quebec G0R2C 0
CA   G0R2C0
Manufacturer Contact
sandrine kake
230 boulevard nilus-leclerc
l'islet, quebec G0R2C-0
CA   G0R2C0
MDR Report Key18839014
MDR Text Key337197959
Report Number3009591865-2023-00016
Device Sequence Number1
Product Code FNL
UDI-Device Identifier00670482000180
UDI-Public010067048200018011200610
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 09/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFL36
Device Catalogue NumberFL36
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-