MAUDE Adverse Event Report: UMANO MEDICAL INC FREEDOM 1000; HOSPITAL BED

Model Number	FM1000
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received pictures of the cable showing that the ground prong was missing, and the connector sections of the cable were melted.Pictures also showed visible burn marks on the head section of the bed.The power cord was then retrieved by the service technician for investigation.Initial findings confirmed that the ground prong was missing and the connector was melted.Conductivity tests on the two remaining power cable pins were performed and found to be conforming.The manufacturer is currently gathering additional information from the customer.Internal tests are being conducted to replicate the thermal event, as this is the first occurrence of a similar event since the device's launch.
Event or Problem Description
Customer reported that a crackling sound and an electrical flash was noticed from a removable power cord connected to the bed.He mentioned that everything stopped once the bed was unplugged.No patient injury was reported.The nurse cut her hand while reaching the bed.A manufacturer service technician visited the site to investigate the device.The power cord was replaced, and the burn mark on the head section of the bed was removed.The bed is now functioning properly.
Additional Manufacturer Narrative
Upon receiving the complaint, umano medical promptly initiated an investigation.As this was the first reported occurrence of a similar issue, several internal tests were conducted on the bed's power cord in an effort to replicate the reported problem.Based on the results of these tests, the most probable root cause was identified as a combination of two contributing factors: 1.Evidence suggests that a cleaning agent may have been sprayed directly into the power cord connector during the cleaning process, contrary to the manufacturer's instructions for use (ifu).2.The cleaning agent used (bleach) had a concentration significantly higher than the levels recommended in the ifu.This combination of factors likely compromised the integrity of the electrical components.The findings and conclusion of the investigation were communicated to the customer.Based on the available evidence, umano medical concluded that the device did not exhibit any malfunction that could have contributed to the reported event.

• Brand Name: FREEDOM 1000
• 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: 21183226
• Report Number: 3009591865-2025-00002
• Device Sequence Number: 12896084
• Product Code: FNL
• UDI-Device Identifier: 00670482000487
• UDI-Public: 010067048200048711210825
• 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: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 08/25/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown