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

Model Number FL36

Device Problem Mechanical Problem (1384)

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

Event Date 10/30/2018

Event Type  malfunction  

Event Description

Service call was placed for a medical bed exit detection system not functioning as expected.There was no patient fall or further adverse event associated with the issue.

• Brand Name: OOK SNOW
• Type of Device: AC POWERED 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 G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 8056138
• MDR Text Key: 128047515
• Report Number: 3009591865-2018-00016
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 010067048200006711161003
• 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,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2016
• 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