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

Model Number FL36

Device Problem Device Alarm System (1012)

Patient Problem Fall (1848)

Event Date 12/08/2023

Event Type  Death  

Manufacturer Narrative

2024-01-11: health care facility ("hcf") contacts umano medical ("um") to retroactively report the incident, namely that the patient fell on (b)(6) 2023, and subsequently died on (b)(6) 2023.2024-01-15: pursuant to hcf's request, regarding the patient fall, a um technician conducts a site visit at the hcf.During the visit, the um technician conducts further tests, and more importantly, fully reviews the computer log history of the medical bed.Such review reveals that no error or malfunction of the medical bed occured on (b)(6) 2023.2024-01-17: to ensure that nothing is disputed, one of um's technical service leaders send an email to hcf summarizing the above-mentioned fact and conclusion.Receipt confirmed by the hcf.The bed is fully functional at customer site, no action required.The most probable cause is a user error.Note: 2024-03-05: resubmitting report in production environment.

Event Description

Based on the information provided by the health care facility ("hcf") on 2024-01-11 to umano medical technical service : (b)(6) 2023: the patient exited the medical bed , thereafter fell, while in its designagted room in the hcf, not confirmed if there was any injury (the " incident").(b)(6) 2023: the patient died for a reason that may, or may not, be directly related to the incident.The patient was already in a deterioration phase as indicated by the hcf representative.

• Brand Name: OOK SNOW
• Type of Device: HOSPITAL BED
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, quebec G0R2C 0; CA G0R2C0
• Manufacturer (Section G): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, quebec G0R2C 0; CA G0R2C0
• Manufacturer Contact: sandrine kake ; 230 boulevard nilus-leclerc; l'islet, quebec G0R2C-0 ; CA G0R2C0
• MDR Report Key: 18839928
• MDR Text Key: 336944163
• Report Number: 3009591865-2024-00001
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death