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

Model Number	FL36
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the bed exit detection system on a medical bed was not functioning properly.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
No defects were found.The most probable cause of this situation appears to be that the calibration had not been done by the user and the instructions for zeroing not followed.Therefore, this would be a user error since the indications for calibration and zeroing are mentioned in the accompanying documentation.Precisions were made to the user manuel (corrective action : res 85592 recall 3009591865-04/28/2020-001-c ) to emphasis the preventive maintenance annual checklist, which includes calibration and to emphasis on usage of detection system and the zeroing procedure, which is explained and described in the user manual.The manufacturer will follow the trend.

• Brand Name: OOK SNOW
• Common Device Name: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, G0R 2 C0; CA G0R 2C0
• MDR Report Key: 8190028
• Report Number: 3009591865-2018-00025
• Device Sequence Number: 13982888
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 45