NELLCOR PM100N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-26 for NELLCOR PM100N manufactured by Mediana Co. Ltd..

Event Text Entries

[181388382] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[181388383] According to the reporter, the unit had wrong saturation measurement. There was no allegation of patient death or serious injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00167
MDR Report Key9755867
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-02-26
Date of Report2020-02-26
Date of Event2020-02-10
Date Mfgr Received2020-02-11
Date Added to Maude2020-02-26
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 FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MEDIANA CO. LTD.
Manufacturer Street1650 1 2 DONGHWA RI MUNMAK EU
Manufacturer CityKANGWON DO WONJU SI 00000
Manufacturer CountryKR
Manufacturer Postal Code00000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNELLCOR
Generic NameOXIMETER
Product CodeDQA
Date Received2020-02-26
Returned To Mfg2020-02-11
Model NumberPM100N
Catalog NumberPM100N
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDIANA CO. LTD.
Manufacturer Address1650 1 2 DONGHWA RI MUNMAK EU KANGWON DO WONJU SI 00000 KR 00000


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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