PARATREND 7 SENSOR MPS7004

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 1996-05-09 for PARATREND 7 SENSOR MPS7004 manufactured by Biomedical Sensors Ltd.

Event Text Entries

[20197875] After four hours of monitoring the temperature reading went to zero. No report of injury has been rec'd.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612233-1996-09004
MDR Report Key40084
Report Source01,08
Date Received1996-05-09
Device Manufacturer Date1996-04-01
Date Added to Maude1996-10-02
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 MONTURING SENSOR
Product CodeCCC
Date Received1996-05-09
Model NumberMPS7004
Catalog NumberMPS7004
Lot Number544
ID NumberNA
Device Expiration Date1997-03-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age*
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key41206
ManufacturerBIOMEDICAL SENSORS LTD
Manufacturer AddressHIGH WYCOMBE BUCKS UK


Patients

Patient NumberTreatmentOutcomeDate
10 1996-05-09

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