SEDLINE SENSOR 2479

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 2017-08-19 for SEDLINE SENSOR 2479 manufactured by Masimo - 40 Parker.

Event Text Entries

[83100577] Attempts have been made to obtain the product. The product involved in this event has not been returned to date to allow for an analysis to be performed. If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[83100578] The customer reported psi too high during use (more than 90 though pt. Was well anesthetized). No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031172-2017-00795
MDR Report Key6806442
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-08-19
Date of Event2017-06-02
Date Mfgr Received2017-08-29
Device Manufacturer Date2017-02-03
Date Added to Maude2017-08-19
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 ContactSTEFAN LISSMANN
Manufacturer Street52 DISCOVERY
Manufacturer CityIRVINE CA 926181604
Manufacturer CountryUS
Manufacturer Postal926181604
Manufacturer Phone9492977000
Manufacturer G1INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
Manufacturer StreetCALZADA DEL ORO, NO. 2001 PARQUE INDUSTRIAL PALACO
Manufacturer CityMEXICALI, BAJA CALIFORNIA 21600
Manufacturer CountryMX
Manufacturer Postal Code21600
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSEDLINE SENSOR
Generic NameELECTROENCEPHALOGRAPH
Product CodeGWQ
Date Received2017-08-19
Returned To Mfg2017-08-07
Model Number2479
Catalog Number2479
Lot Number17B29
Device Expiration Date2019-10-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMASIMO - 40 PARKER
Manufacturer Address40 PARKER IRVINE CA 926181604 US 926181604


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-19

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