GAS CYLINDER PRESSURE REGULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for GAS CYLINDER PRESSURE REGULATOR manufactured by Airgas Usa.

Event Text Entries

[131340901] On (b)(6) 2018 service technician discovered odor at carbon dioxide gas manifold coming from one cylinder. Co2 outlets were tested. Tests indicated elevated levels of hydrocarbons in the c02 line, not meeting nfpa99 standards. C02 regulator and parts of manifold were found damaged and were replaced. C02 was used during laparoscopic surgery for insufflation or during cardiovascular surgery for oxygen displacement/ surgical fire prevention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082397
MDR Report Key8189623
Date Received2018-12-20
Date of Report2018-11-23
Date of Event2018-06-22
Date Added to Maude2018-12-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGAS CYLINDER PRESSURE REGULATOR
Generic NameGAS CYLINDER PRESSURE REGULATOR
Product CodeCAN
Date Received2018-12-20
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAIRGAS USA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-20

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