PRESSURE MONITORING KIT T100209B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2020-01-06 for PRESSURE MONITORING KIT T100209B manufactured by Edwards Lifesciences Dr.

Event Text Entries

[188674458] The device evaluation is anticipated. However, the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation and device history results when received.
Patient Sequence No: 1, Text Type: N, H10


[188674459] It was reported that when this pressure monitoring set was connected after the placement of an arterial catheter in a patient, the blood pressure was? Discordant.? The blood pressure was verified with the arm cuff and there was a difference of 150 mmhg. The problem solved after changing the blood pressure sensor. There was no allegation of patient injury reported. Device was available for evaluation. Patient demographics were unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2020-10050
MDR Report Key9555785
Report SourceCOMPANY REPRESENTATIVE,OTHER,
Date Received2020-01-06
Date of Report2019-12-16
Date of Event2019-12-14
Date Mfgr Received2020-01-15
Device Manufacturer Date2019-07-09
Date Added to Maude2020-01-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS SAMANTHA EVELEIGH
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492503939
Manufacturer G1EDWARDS LIFESCIENCES DR
Manufacturer StreetPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRESSURE MONITORING KIT
Generic NameTRANSDUCER, PRESSURE, CATHETER TIP
Product CodeDXO
Date Received2020-01-06
Returned To Mfg2020-01-09
Model NumberT100209B
Catalog NumberT100209B
Lot Number62396559
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES DR
Manufacturer AddressPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-06

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