NELLCOR D-YS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-05 for NELLCOR D-YS manufactured by Nellcor Puritan Bennett Mexico Sa.

Event Text Entries

[182169120] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182169121] According to the reporter, the unit had system failure errors with both cables switched between machines despite battery changes. The unit usually had low reading ranging 90's, 90-93. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00185
MDR Report Key9792318
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-05
Date of Report2020-03-05
Date Mfgr Received2020-02-26
Device Manufacturer Date2018-07-27
Date Added to Maude2020-03-05
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 G1NELLCOR PURITAN BENNETT MEXICO SA
Manufacturer StreetBOULEVARD INSURGENTES 19030
Manufacturer CityTIJUANA 22225
Manufacturer CountryMX
Manufacturer Postal Code22225
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNELLCOR
Generic NameOXIMETER
Product CodeDQA
Date Received2020-03-05
Model NumberD-YS
Catalog NumberD-YS
Lot Number182150039H
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNELLCOR PURITAN BENNETT MEXICO SA
Manufacturer AddressBOULEVARD INSURGENTES 19030 TIJUANA 22225 MX 22225


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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