OXIMAX N-595 PULSE OXIMETER N595

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-07 for OXIMAX N-595 PULSE OXIMETER N595 manufactured by Covidien.

Event Text Entries

[4909506] It was reported to covidien that this unit does not have audio. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[11924887] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936999-2014-00739
MDR Report Key4060257
Report Source06,07
Date Received2014-08-07
Date of Report2014-08-01
Date of Event2014-01-01
Date Mfgr Received2014-08-01
Device Manufacturer Date2002-09-01
Date Added to Maude2014-09-10
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 G1COVIDIEN
Manufacturer StreetMICHAEL COLLINS ROAD NEW MERVUE INDUSTRIAL PARK
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXIMAX N-595 PULSE OXIMETER
Generic NamePULSE OXIMETER
Product CodeDPZ
Date Received2014-08-07
Model NumberN-595
Catalog NumberN595
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressNEW MERVUE INDUSTRIAL PARK GALWAY


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-07

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