OXIMAX N-560 PULSE OXIMETER N560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07 report with the FDA on 2014-04-08 for OXIMAX N-560 PULSE OXIMETER N560 manufactured by Mediana.

Event Text Entries

[17932203] It was reported to covidien that part of the heart rate reading was lacking. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5


[18233685] The circuit that displays the segments had a connection failure. The front board was replaced and the problem resolved. (b)(4). The serial number of the display pcb precedes a corrective and preventive action taken by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936999-2014-00295
MDR Report Key3880249
Report Source00,01,06,07
Date Received2014-04-08
Date of Report2014-03-10
Date of Event2014-03-06
Date Mfgr Received2014-03-10
Device Manufacturer Date2013-03-01
Date Added to Maude2014-07-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDENISE BRAXTON
Manufacturer Street6135 GUNBARREL AVE.
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3038768909
Manufacturer G1MEDIANA
Manufacturer StreetWONJU INDUSTRY PARK DONGWHA-RI, MUNMAK-EUP, WONJU-SI
Manufacturer CityGANGWON-DO
Manufacturer CountryKS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXIMAX N-560 PULSE OXIMETER
Generic NamePULSE OXIMETER
Product CodeDPZ
Date Received2014-04-08
Returned To Mfg2014-03-18
Model NumberN-560
Catalog NumberN560
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDIANA
Manufacturer AddressWONJU INDUSTRY PARK DONGWHA-RI, MUNMAK-EUP GANGWON KS


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-08

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