AMVEX MINI CLICK STYLE GAS REGULATOR EB-GPM2-870RM-T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for AMVEX MINI CLICK STYLE GAS REGULATOR EB-GPM2-870RM-T manufactured by Ohio Medical Llc.

Event Text Entries

[141374941] During normal use, device suddenly started flowing high pressure oxygen out of the pressure relief hole. This is one of multiple reports you will receive for the same model (different serial numbers) device with exactly the same failure. Mfr was notified multiple times with acknowledgement that a problem exists. Replacement units also failed. Device click knob also was not secure. Routinely came off of device. Oxygen tubing nipple also not secure. We constantly experienced the nipple separating from the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085650
MDR Report Key8495914
Date Received2019-04-08
Date of Report2019-08-11
Date Added to Maude2019-04-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMVEX MINI CLICK STYLE GAS REGULATOR
Generic NamePORTABLE OXYGEN REGULATOR / REGULATOR VACUUM
Product CodeCAN
Date Received2019-04-08
Model NumberEB-GPM2-870RM-T
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOHIO MEDICAL LLC
Manufacturer Address1111 LAKE SIDE DR. GURNEE IL 60031 US 60031


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-08

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