MAUDE Adverse Event Report: UMANO MEDICAL INC. FREEDOM1000; HOSPITAL BED

Model Number	FM1000
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Distributer contacted technical service of the manufacturer to report an issue with the motorized wheel system of a hospital bed that was being used by one of his customers during a trial session (the bed was not in use with a patient) he mentioned that when they released the trigger to stop the wheel movement, the bed continued to move forward and was stopped against the wall.There was no patient involvement and no adverse.
Additional Manufacturer Narrative
A recall has been initiated on the 11th of april 2022 by umano medical inc related to this problem.The motorized wheel software will be modified to add monitoring conditions to continuously monitor the motor status including when it should not be running.This recall number res#: 90058 is still in progress.

• Brand Name: FREEDOM1000
• 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: 13892885
• Report Number: 3009591865-2022-00005
• Device Sequence Number: 4793595
• Product Code: FNL
• UDI-Device Identifier: 00670482000487
• UDI-Public: 010067048200048711211006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: FM1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES#90058
• Patient Sequence Number: 1
• Patient Sex: Unknown