NELLCOR 10005941

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for NELLCOR 10005941 manufactured by Mediana Co. Ltd..

Event Text Entries

[182770958] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182770959] According to the reporter, the unit had low spo2 reading. It was indicated that desaturation and tachycardia record for spo2 readings was 76% and heart rate of 239 but newborn did not manifest any signs of distress. Follow up report stated that there was no death or any patient injury accompanied with customer complaint on the fluctuation of reading and the first feedback was not accurate and was related to another event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00198
MDR Report Key9811865
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-10
Date of Report2020-03-10
Date of Event2020-02-17
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-10
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 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 Received2020-03-10
Model Number10005941
Catalog Number10005941
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
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 2020-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.