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

Model Number	FL36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient fell off a medical bed.The initiator reported and alledged that the "primary care physician was in the room and watched the bed alarm start to go off, not sound, and then turn off while the patient fell.The patient was not reported to be injured.".
Additional Manufacturer Narrative
Upon receiving the complaint on 2025-10-13, umano medical promptly initiated an investigation by reviewing the dhr.The bed was fully tested and had passed all required tests during production.No nonconformity related to the alleged issue was identified.Initial information was received from the distributor, who was expected to conduct an on site investigation.On 2025-10-27, umano medical performed a follow-up by email.On 2025-10-28, the distributor confirmed that they had not yet completed their investigation or testing and would get back to us.Between 2025-11-04 and 2025-12-16, umano medical sent three additional follow-up emails.No responses were received.A follow-up phone call was made on 2026-01-20, but there was no answer, and a voicemail was left.As of 2026-01-27, no reply had been received.Given the absence of information from the distributor, it was determined that the investigation could not be completed.Therefore, no root cause could be identified, and the complaint was closed.

• 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: 23522927
• Report Number: 3009591865-2025-00027
• Device Sequence Number: 13286236
• Product Code: FNL
• UDI-Device Identifier: 00670482000180
• UDI-Public: 010067048200018011191206
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/16/2026

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?: No
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 12/06/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown