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

Model Number	FL36
Medical Device Problem Codes	Sparking (2595); Battery Problem (2885); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: (b)(6)2024 resubmitting report in production environment.Kindly see attachment.
Event or Problem Description
The customer reported to the technical service of the manufacturer that when they plugged the bed in their outlet it sparks, and smoke came out of the outlet , causing the facility breaker to trip.No adverse consequence were reported.

• Brand Name: OOK SNOW
• 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: 18839014
• Report Number: 3009591865-2023-00016
• Device Sequence Number: 7439622
• Product Code: FNL
• UDI-Device Identifier: 00670482000180
• UDI-Public: 010067048200018011200610
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 09/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• 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