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

Model Number	FL36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was inspected, bed exit functionality verified and all were found conform to specifications.
Event or Problem Description
While at establishment for bed exit system verification on a ook snow medical bed, service technician from the manufacturer was informed of a patient fall that occured weeks before the service visit.Site confirmed there were no injury but not further details could be confirmed.

• Brand Name: OOK SNOW
• Common Device Name: MEDICAL ELECTRIC BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• MDR Report Key: 7427168
• Report Number: 3009591865-2018-00008
• Device Sequence Number: 112543
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 00670482000067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Service and Testing Personnel
• Device Model Number: FL36
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1