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

Model Number	OOK SNOW
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was being restraint in bed with head and foot siderails raised up, that the patient was able to get out of the bed through a space at the foot end of the bed, that patient took a walker, walked and fell.It was reported that the staff was not using the bed exit monitoring system as the siderails are seen and used as restraint in their protocol.

• 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: 6959511
• Report Number: 3009591865-2017-00001
• Device Sequence Number: 16342548
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2017

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: No Information
• Device Model Number: OOK SNOW
• Device Catalogue Number: FL36
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other