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

Model Number	200-0000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bed-exit alarm allegedly failed to transmit a signal to the nurse call panel.No injuries were reported.

• Brand Name: OOK SNOW ALL
• 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: 23843430
• Report Number: 3009591865-2025-00039
• Device Sequence Number: 9835379
• Product Code: FNL
• UDI-Device Identifier: 00670482000494
• UDI-Public: 010067048200049411220829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/18/2025

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: 200-0000
• Device Catalogue Number: 200-0000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2022
• 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 Number: 1
• Patient Sex: Unknown