OXIMAX N595

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2015-03-03 for OXIMAX N595 manufactured by Covidien.

Event Text Entries

[15245282] It was reported that during testing of the pulse oximeter the sound delivered from the speaker sounded "weak and raspy". There was no reported patient involvement. There is no report of death or serious injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5


[15550115] (b)(4). A technical support engineer (tse) assisted the distributor with troubleshooting the device via phone. Upon visual inspection of the device, the distributor found the speaker wires to be pinched. The distributor stated neither the device nor it's components will be returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2936999-2015-00185
MDR Report Key4564983
Report Source05,08
Date Received2015-03-03
Date of Report2015-02-09
Date Mfgr Received2015-02-09
Device Manufacturer Date2002-07-19
Date Added to Maude2015-04-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDENISE BRAXTON
Manufacturer Street6135 GUNBARREL AVENUE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3038768909
Manufacturer G1COVIDIEN
Manufacturer StreetNEW MERVUE INDUSTRIAL PARK MICHAEL COLLINS ROAD
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOXIMAX
Generic NamePULSE OXIMETER
Product CodeDPZ
Date Received2015-03-03
Model NumberN595
Catalog NumberN595
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressNEW MERVUE INDUSTRIAL PARK MICHAEL COLLINS ROAD GALWAY EI


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-03

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