NEOTREND-L SENSOR N7004L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-05-28 for NEOTREND-L SENSOR N7004L manufactured by Diametrics Medical Limited.

Event Text Entries

[377735] Neotrend-l sensor calibrated successfully, but unable to insert greater than 2cm into umbilical artery catheter. No report of adverse event or patient-related problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-2004-00008
MDR Report Key588998
Report Source07
Date Received2004-05-28
Date of Report2004-02-01
Date of Event2004-01-01
Date Mfgr Received2004-05-20
Device Manufacturer Date2003-02-01
Date Added to Maude2005-04-11
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 Location0
Manufacturer ContactMISS J WALTERS
Manufacturer StreetSHORT STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112QH
Manufacturer CountryUK
Manufacturer PostalHP11 2QH
Manufacturer Phone494471671
Manufacturer G1DIAMETRICS MEDICAL LTD
Manufacturer StreetGEORGE STREET, HIGH WYCOMBE
Manufacturer CityBUCKS HP112XJ
Manufacturer CountryUK
Manufacturer Postal CodeHP11 2XJ
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNEOTREND-L SENSOR
Generic NameBLOOD GAS MONITORING SYSTEM
Product CodeCCE
Date Received2004-05-28
Returned To Mfg2004-03-15
Model NumberN7004L
Catalog NumberN7004L
Lot Number884
ID Number*
Device Expiration Date2004-07-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key578846
ManufacturerDIAMETRICS MEDICAL LIMITED
Manufacturer AddressGEORGE STREET HIGH WYCOMBE, BUCKS. UK HP11 2XJ
Baseline Brand NameNEOTREND-L MULTIPARAMETER SENSOR
Baseline Generic NameNEOTREND
Baseline Model NoN7004L
Baseline Catalog NoN7004L
Baseline IDNA
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]18
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK972314
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2004-05-28

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