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

Model Number	200-0000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported to the technical service of manufacturer that both breaking/steer bar assemblies of the bed were completely ripped off.There was no patient involvement.
Additional Manufacturer Narrative
Note: 2024-03-05: resubmitting report in production environment.

• Brand Name: OOK SNOW ALL
• Common Device Name: 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 Key: 18839779
• Report Number: 3009591865-2023-00021
• Device Sequence Number: 12589808
• Product Code: FNL
• UDI-Device Identifier: 00670482000142
• UDI-Public: 010067048200014211181127
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2018
• 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