MAUDE Adverse Event Report: MEDIANA CO. LTD. COMPAT ENTERAL FEEDING TUBE 12FR 120CM WITH STYLET

Model Number	N560
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had display failure.The customer also stated there was missing segments every digit.There was no patient involvement.
Additional Manufacturer Narrative
Additional info: g4, h3, h6 h3 evaluation summary: one device with serial number (b)(4) was received for evaluation.The reported event was confirmed.The investigation isolated the failure of the observed condition to the faulty display board.The device has reached its end of life (eol).Replacement parts are not available and the device was not repaired.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COMPAT ENTERAL FEEDING TUBE 12FR 120CM WITH STYLET
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• MDR Report Key: 9538087
• Report Number: 2936999-2020-00004
• Device Sequence Number: 3414721
• Product Code: PIF
• UDI-Device Identifier: 08056093720976
• UDI-Public: 08056093720976
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K181787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: Health Professional
• Device Model Number: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1