OXIMETER 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 01,06,07 report with the FDA on 2014-06-18 for OXIMETER N-560 PULSE OXIMETER N560 manufactured by Mediana.

Event Text Entries

[4611090] It was reported to covidien that the unit had a blank display. Covidien technician found that the unit had segments missing in the display. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5


[12150560] Covidien service ctr replaced the front pcb and main board. (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 Number2936999-2014-00525
MDR Report Key3963284
Report Source01,06,07
Date Received2014-06-18
Date of Report2014-06-12
Date of Event2014-05-01
Date Mfgr Received2014-06-12
Device Manufacturer Date2013-03-01
Date Added to Maude2014-08-04
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 CityGONGWON-DO
Manufacturer CountryKN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXIMETER N-560 PULSE OXIMETER
Generic NamePULSE OXIMETER
Product CodeDPZ
Date Received2014-06-18
Returned To Mfg2014-05-23
Model NumberN-560
Catalog NumberN560
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDIANA
Manufacturer AddressDONGWHA-RI, MUNMAK-EUP GANGWON KN


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-18

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