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

Model Number	FL36
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Service call was placed for a medical bed exit detection system arming sporadically when patient returns in bed.There was no patient fall or further adverse event associated with the detection system.

• Brand Name: OOK SNOW
• Common Device Name: AC POWERED MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• MDR Report Key: 8053209
• Report Number: 3009591865-2018-00015
• Device Sequence Number: 1806797
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: Health Professional
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1