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

Model Number PRX-9369

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A report was received from (b)(6) that is as follows: while performing a test on an oxygen cylinder with a valve integrated pressure regulating device that was in inventory, the unit apparently did not provide the correct flow of oxygen at the flow setting.The unit was not in use at the time of test.There was no patient involved.

Manufacturer Narrative

Upon testing, the regulator exhibited inconsistent and unstable flow rates at the various flow positions when rotating the knob in both the ascending or descending directions.Upon disassembly, it was noted that there ws no evidence of internal moisture in the regulator and the orifice plate rotated freely within the housing.The positional relationship was found to be good between the knob shaft, orifice plate, flow control housing, and the body.Further inspection of the flow control mechanism found the elastomer compression sleeve, which provides the seal between the housing and the orifice plate, to be distorted or partially collapsed.When this occurs, the seal between the housing and the orifice locations on the plate can become misaligned, resulting in flow restriction and/or variability at the detent flow positions.After disassembly and removal from the housing, the compression sleeve returned closer to its original shape.Analysis has shown that this failure mode is of a delayed and intermittent nature and cycling the flow control knob has caused the unit to resume normal operations.

• Brand Name: PRAXIAR GRAB 'N GO III
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): PRAXAIR HEALTHCARE; 175 east park dr.; specification developer; tonawanda NY 14151
• Manufacturer (Section G): SCOTT FETZER CO.; 875 bassett rd.; cleveland OH 44145
• Manufacturer Contact: michael skrjanc ; 175 east park dr.; tonawanda, NY 14151 ; 3309493324
• MDR Report Key: 3770314
• MDR Text Key: 4378648
• Report Number: 1000448358-2014-00002
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• 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: 0904332280
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2000
• 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