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

Model Number 200-0000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Note: 2024-03-05: resubmitting report in production environment.

• Brand Name: OOK SNOW ALL
• Type of Device: 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
• MDR Text Key: 337758656
• Report Number: 3009591865-2023-00021
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00670482000142
• UDI-Public: 010067048200014211181127
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1