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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIANA OXIMAX N-560 PULSE OXIMETER
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MEDIANA OXIMAX N-560 PULSE OXIMETER Back to Search Results
Model Number N-560
Device Problems Component Missing (2306); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Date 01/14/2014
Event Type  malfunction  
Event Description
It was reported to covidien that the display does not show the correct values.Missing segments in the display.There was no patient involved.
 
Manufacturer Narrative
Covidien service engineer from poland states there was electrical break between the segment display and the display panel.The electric connectors on the display board have been fixed.The manufacture date is unknown for the serial number provided.Covidien (b)(4).
 
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Brand Name
OXIMAX N-560 PULSE OXIMETER
Type of Device
PULSE OXIMETER
Manufacturer (Section D)
MEDIANA
wonju industry park
dongwha-ri, munmak-eup
gangwon-do
KN 
Manufacturer (Section G)
MEDIANA
wonju industry park
dongwha-ri, munmak-eup, wonju-si
gangwon-do
KN  
Manufacturer Contact
denise braxton
6135 gunbarrel ave.
boulder, CO 80301
3038768909
MDR Report Key3937953
MDR Text Key18091086
Report Number2936999-2014-00197
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K012891
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 02/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN-560
Device Catalogue NumberN560
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/14/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/21/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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