MAUDE Adverse Event Report: PRAXAIR HEALTHCARE PRAXAIR GRAB 'N GO III; REGULATOR, PRESSURE, GAS CYLINDER

Model Number PRX-9369

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

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

Event Date 01/07/2014

Event Type  malfunction  

Event Description

A report was received from (b)(6) that an oxygen cylinder with a valve integrated pressure regulating device did not provide oxygen flow.Another oxygen cylinder with the same valve was used to supply oxygen to the patient.There was no report of any injury to the patient.

Manufacturer Narrative

Upon disassembly of the unit, a small amount of moisture was detected in the regulator's low pressure cavity, particularly on the backside of the flow control housing.It was found that the orifice plate was seized in the bonnet.The seized orifice plate prevented flow selection.The cause of the failure appears to be the moisture which can cause the nylon orifice plate to swell.In such a condition, subsequent rotation of the flow control knob can cause the orifice plate to become stripped from the flow control shaft so that the shaft rotates independently from the orifice plate.This can result in the loss of flow control or a no flow condition, depending upon the position of the orifice plate.In this instance, it was confirmed that the orifice plate was seized in the "off" position, which explains the observed no flow condition.Western was unable to identify the exact source of the moisture.This valve was replaced.

• Brand Name: PRAXAIR GRAB 'N GO III
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): PRAXAIR HEALTHCARE; 175 east park dr.; tonawanda NY 14150
• Manufacturer (Section G): WESTERN/SCOTT FETZER CO.; 875 bassett rd.; cleveland OH 44145
• Manufacturer Contact: michael skrjanc ; 175 east park drive; tonawanda, NY 14150 ; 3309493324
• MDR Report Key: 3865265
• MDR Text Key: 4589669
• Report Number: 1000448358-2014-00001
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRX-9369
• Device Lot Number: O904332677
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1