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

Model Number FL36

Device Problem Failure to Zero (1683)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

Verifications made over the phone indicated that 1 of 2 beds was presenting a zero that had not been made.The scale display indicated - 48 lb.The manufacturer could not retrieve further details on patient condition.Based on service parts required and, on information available to the manufacturer, it was established that the most probable cause was a use error that contributed to make detection system unable to detect the patient exiting the bed (ie.Zero not made).Date of event is unknown, occured in 2017 or 2018.

Event Description

While in communication with establishment for service parts, the manufacturer was informed that a patient got up [of a ook snow bed ] and the alarm did not went off.It was alleged that the patient did fall as a result.

• Brand Name: OOK SNOW
• Type of Device: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; quebec G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; quebec G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: maude thibault ; 230 boulevard nilus-leclerc; quebec G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 7337624
• MDR Text Key: 102338060
• Report Number: 3009591865-2018-00004
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00670482000067
• UDI-Public: 00670482000067
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/14/2018
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: No
• 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