MAUDE Adverse Event Report: PARKER HANNIFIN CORP. NITRONOT

Model Number NOX-500D

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

Event Type  Injury  

Event Description

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.

• Brand Name: NITRONOT
• Type of Device: NITRONOT
• Manufacturer (Section D): PARKER HANNIFIN CORP.; hatfield PA 19440
• MDR Report Key: 6266338
• MDR Text Key: 65512400
• Report Number: MW5067332
• Device Sequence Number: 1
• Product Code: CAX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOX-500D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention