PRESSURE REDUCTION VALVE 20132-065

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-04-09 for PRESSURE REDUCTION VALVE 20132-065 manufactured by Linde Ag.

Event Text Entries

[131460] Pressure reduction valve (prv) is a component to erbe usa's argon plasma coagulator. The prv is not manufactured by erbe. The mfr used an incorrect connector on the prv. Customer reported that the prv was difficult to thread into the argon tank. Prv was returned to erbe usa. Prv was never orused at the account. No pt was involved; no pt injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number1057212-1999-00002
MDR Report Key218303
Date Received1999-04-09
Date of Report1999-04-09
Date of Event1999-03-18
Date Facility Aware1999-03-18
Report Date1999-04-09
Date Reported to Mfgr1999-03-30
Date Added to Maude1999-04-13
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRESSURE REDUCTION VALVE
Generic NamePRESSURE REDUCTION VALVE
Product CodeMNJ
Date Received1999-04-09
Model Number20132-065
Catalog Number20132-065
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityY
Device Age3 MO
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key211716
ManufacturerLINDE AG
Manufacturer Address* * GM
Baseline Brand NamePRESSURE REDUCTION VALVE
Baseline Generic NamePRESSURE REDUCTION VALVE
Baseline Model No20132-065
Baseline Catalog No20132-065
Baseline ID*

Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-04-09
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