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

Model Number	FL36
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Service department was contacted for an integrated bed exit detection system allegedly not operating adequatly in lower position.User reports that there is a delay in the alarm for detection of the patient exiting the bed when bed sleep surface is lowered.

• Brand Name: OOK SNOW
• 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: 9292758
• Report Number: 3009591865-2019-00018
• Device Sequence Number: 2310577
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 010067048200006711161003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: Health Professional
• Device Model Number: FL36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1