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

Model Number FL36

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/23/2022

Event Type  Injury  

Event Description

Technical service of the manufacturer was informed that a patient has fallen on the ground and hurt his forehead.Customer mentioned that integrated bed exiting detection system did not ring when a patient left his bed.

• Brand Name: OOK SNOW
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: saoussen gammoudi ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 15708058
• MDR Text Key: 302771739
• Report Number: 3009591865-2022-00029
• Device Sequence Number: 1
• Product Code: FNL
• 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
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FL36
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other