MAUDE Adverse Event Report: UMANO MEDICAL INC. OOK SNOW ALL; AC POWERED ADJUSTABLE HOSPITAL BED

Model Number	200-0000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Technical service department of the manufacturer was contacted by client reporting that a "rn walked into room at approximately 2am and found patient on the ground kneeling next to the bed.Bed exit alarms was not set because rn stated that she "didn't know how".Unknown if patient felt." it was further reported that patient re-broke their pelvis.

• Brand Name: OOK SNOW ALL
• Common Device Name: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, G0R 2 C0; CA G0R 2C0
• MDR Report Key: 10203274
• Report Number: 3009591865-2020-00009
• Device Sequence Number: 16398885
• Product Code: FNL
• UDI-Device Identifier: 00670482000142
• UDI-Public: 010067048200014211200109
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: 200-0000
• Device Catalogue Number: 200-0000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: Other