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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIANA CO. LTD. COMPAT ENTERAL FEEDING TUBE 12FR 120CM WITH STYLET
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MEDIANA CO. LTD. COMPAT ENTERAL FEEDING TUBE 12FR 120CM WITH STYLET Back to Search Results
Model Number N560
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event 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.
 
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.
 
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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 Key9538087
MDR Text Key178118022
Report Number2936999-2020-00004
Device Sequence Number1
Product Code PIF
UDI-Device Identifier08056093720976
UDI-Public08056093720976
Combination Product (y/n)N
PMA/PMN Number
K181787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN560
Device Catalogue NumberN560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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