MAUDE Adverse Event Report: UMANO MEDICAL INC. OOK SNOW; HOSPITAL BED

Model Number	FL36
Medical Device Problem Codes	Arcing (2583); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cable of a hospital bed was allegedly emitting smoke.No injuries were reported.

• 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: martine bertrand ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 24806319
• Report Number: 3009591865-2026-00006
• Device Sequence Number: 9548438
• Product Code: FNL
• UDI-Device Identifier: 00670482000685
• UDI-Public: 010067048200068511250327
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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 Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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 Number: 1
• Patient Sex: Unknown