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

Model Number FL36

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

Event Description

Service support of the manufacturer was contacted for a bed exit detection system allegedly staying armed after patient had exited the bed.There was no injury to the patient or any further issue.

• Brand Name: OOK SNOW
• Type of Device: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: maude thibault ; 230 boulevard nilus-leclerc; l'islet, quebec ; CA
• MDR Report Key: 8162038
• MDR Text Key: 130337059
• Report Number: 3009591865-2018-00022
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 010067048200006711171002
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other