MAUDE Adverse Event Report: UMANO MEDICAL INC FREEDOM 500; MEDICAL BED

Model Number	FM500
Medical Device Problem Codes	Component Missing (2306); Out-Of-Box Failure (2311); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that a bed model fm500 was found with a support arm disassembled from a footend rail.The bed was not in service, the situation was noticed during inspection of bed.There were no reported adverse event.

• Brand Name: FREEDOM 500
• Common Device Name: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• MDR Report Key: 7133521
• Report Number: 3009591865-2017-00004
• Device Sequence Number: 1310549
• Product Code: FNL
• UDI-Device Identifier: 00670482000081
• UDI-Public: 00670482000081
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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: Other
• Device Model Number: FM500
• Device Catalogue Number: FM500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1