NITRONOT NOX-500D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-17 for NITRONOT NOX-500D manufactured by Parker Hannifin Corp..

Event Text Entries

[65512400] This is word from parker on their nitronox machine with my concerns that they have pressure gauges with a green zone, where they tell the user the incoming pressure should read in the green zone at 50-55 psi but then they have this addendum that states different (see below). I feel that parker needs to change the pressure gauges of incoming pressures to not have a green zone that staff does not have conflicting reports on how to use the equipment. Parker hannifin corporation (b)(4). (b)(6) 2017 re: nitronox line pressure readings to whom it may concern: facilities that are using gas supply from central lines (wall source) most likely will not have the ability to make an adjustment to the psi from the tank room to the wall source. It is "preferable" (not required) that the nitronox line pressure be within the "green band" on the line pressure gauge (as referenced in the user manual - see below). The line pressure gauges are also not "precision" gauges and there could be potential for a small psi +/- variance on what the gauge shows vs actual. As noted in the manual the line pressure supply is required to be 40-65 psi. The critical line pressure gauge visual is confirmation that the variance between o2 and n2o line pressures do not exceed 15psi. An example would be o2 line pressure = 45psi and n2o line pressure = 60psi. In this scenario the device should be taken out of service - and follow the user manual instructions for adjustment or service. In excess of 15psi line pressure differential could potentially alter the 50/50 blend of the two gases.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067332
MDR Report Key6266338
Date Received2017-01-17
Date of Report2017-01-17
Date of Event2017-01-17
Date Added to Maude2017-01-20
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 Report0

Device Details

Brand NameNITRONOT
Generic NameNITRONOT
Product CodeCAX
Date Received2017-01-17
Model NumberNOX-500D
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPARKER HANNIFIN CORP.
Manufacturer AddressHATFIELD PA 19440 US 19440


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-01-17

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