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

Model Number	FL36
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation concluded that bed head siderail had interfered with fixed shelf in the room while elevation system being raised.
Event or Problem Description
Manufacturer representative was contacted by user site alleging that the left head siderail was no longer fixed in place.There was no related injury.

• Brand Name: OOK SNOW MH
• Common Device Name: AC POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• MDR Report Key: 9945880
• Report Number: 3009591865-2020-00006
• Device Sequence Number: 14033496
• Product Code: FNL
• UDI-Device Identifier: 00670482000135
• UDI-Public: 010067048200013511190619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1