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

Model Number	FL36
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fastener felt off from a siderail transfer plate while the device, a ook-cocoon medical bed, was being inspected prior to initial inservicing.This was a out of the box issue, the device had not been put in service.

• Brand Name: OOK COCOON
• Common Device Name: MEDICAL BED
• Manufacturer (Section D): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, quebec G0R 2 C0; CA G0R 2C0
• MDR Report Key: 7381226
• Report Number: 3009591865-2018-00006
• Device Sequence Number: 11081178
• Product Code: FNL
• UDI-Device Identifier: 00670482000111
• UDI-Public: 0670482000111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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: Biomedical Engineer
• Device Model Number: FL36
• Device Catalogue Number: FL36
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1