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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 Problem Improper Device Output (2953)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2014
Event Type  malfunction  
Event Description
Covidien received a report of a n560 that did not display the top line of the segments.No patient involvement reported.
 
Manufacturer Narrative
(b)(4).Covidien service tech verified the top line of display segments were intermittently missing, and replaced the front pcb board.The manufacturer date of the device precedes a corrective action taken by the manufacturer.
 
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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
wonj-si, gangwon-do
KN 
Manufacturer (Section G)
MEDIANA
wonju medical industry park
dongwha-ri, munmak-eup
wonj-si, gangwon-do
KN  
Manufacturer Contact
denise braxton
6135 gunbarrel ave.
boulder, CO 80301
3038768909
MDR Report Key4092734
MDR Text Key4830117
Report Number2936999-2014-00742
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeLO
PMA/PMN Number
K012891
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2014
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 Manufacturer07/29/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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