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

Model Number OXM-AEGNGVTG

Device Problems Inaccurate Flow Rate (1249); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

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

Event Date 04/08/2015

Event Type  malfunction  

Event Description

A report was received from (b)(6) medical center, that a grab 'n go vantage oxygen unit did not provide enough flow oxygen.The unit was being used on a patient that was in transport within the hospital.There was no injury to the patient.Another grab 'n go vantage oxygen unit was obtained and used to administer oxygen to the patient during transport.The grab 'n go vantage is a class i valve integrated pressure regulating device, which is installed into an aluminium high pressure gaseous medical oxygen usp cylinder.

Manufacturer Narrative

The unit was shipped back to western (the contract manufacturer) under (b)(4) and was received on april 15, 2015.The investigation by western is ongoing.

• Brand Name: PRAXAIR GRAB 'N GO VANTAGE
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): PRAXAIR HEALTHCARE SERVICES; 175 east park dr.; tonawanda NY 14151
• Manufacturer Contact: michael skrjanc ; 175 east park dr.; tonawanda, NY 14150 ; 3309493324
• MDR Report Key: 4755980
• MDR Text Key: 5890952
• Report Number: 1000448358-2015-00003
• 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: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OXM-AEGNGVTG
• Device Lot Number: 0864509632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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