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

Model Number	FL36
Medical Device Problem Codes	Defective Alarm (1014); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a customer reported to the manufacturer's technical service that the bed exit monitoring system was triggering an alarm immediately upon arming.The site's technician initiated troubleshooting, but the issue remained unresolved.Troubleshooting was scheduled to continue the following day, and the medical staff continued to use the device.On (b)(6) 2024, during troubleshooting, the site's technician informed the manufacturer that a patient had fallen from the bed the previous night (exact date and time not disclosed).The bed activity log confirmed that the bed exit monitoring system was activated at 21:03 and an alarm was triggered at 8:41.

• 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 Key: 21162327
• Report Number: 3009591865-2025-00001
• Device Sequence Number: 9356042
• Product Code: FNL
• UDI-Device Identifier: 00670482000500
• UDI-Public: 010067048200050011220201
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FL36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown