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

Model Number FL36

Device Problem Use of Device Problem (1670)

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

Event Date 11/13/2018

Event Type  Injury  

Event Description

User contacted service support for an integrated bed exit detection system allegedly not working properly.Patient "felt" with scratch on the scalp; no medical intervention was required.

• 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: 8148109
• MDR Text Key: 129828183
• Report Number: 3009591865-2018-00021
• Device Sequence Number: 1
• Product Code: FLN
• UDI-Device Identifier: 00670482000104
• UDI-Public: 010067048200010411180626
• 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,user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/10/2018

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: Health Professional
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• 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