PARATREND 7 SENSOR MPS 7004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1997-01-03 for PARATREND 7 SENSOR MPS 7004 manufactured by Biomedical Sensors Ltd.

Event Text Entries

[40141] Customer reported that during measurement. The ph reading showed 9. 99. No report of injury has been received.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-1996-90009
MDR Report Key62362
Report Source01,08
Date Received1997-01-03
Date of Report1996-12-19
Date of Event1996-12-14
Date Mfgr Received1996-12-17
Device Manufacturer Date1995-12-01
Date Added to Maude1997-01-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePARATREND 7 SENSOR
Generic NameBLOOD GAS MONITORING SENSOR
Product CodeCCC
Date Received1997-01-03
Model NumberPARATREND 7 SENSOR
Catalog NumberMPS 7004
Lot Number472
ID Number*
Device Expiration Date1996-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key62678
ManufacturerBIOMEDICAL SENSORS LTD
Manufacturer AddressGEORGE ST HIGH WYCOMBE BUCKS UK HPII 2XJ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-01-03

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