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

Model Number PRX-9500

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The system was shipped back to western (the contract manufacturer) under (b)(4) and was received on june 22, 2016.The investigation to date has not yet been completed.

Event Description

A report was received from (b)(6) hospital in (b)(6) that a grab 'n go vantage oxygen valve sheared from the cylinder to which it was attached.The administrator stated that the unit was placed at the foot of a patient's bed by a (b)(6) employee for transport to and from dialysis and acknowledged that on return to the patient's room, the cylinder was not properly secured but remained at the foot of the bed laying on its side with the head towards the window and cylinder toward the door.According to the administrator, after the patient was returned to the room, it appears the patient adjusted the bed upward and the cylinder became lodged between the foot board and the mattress.As the bed was adjusted upward, the force of the bed on the cylinder caused the grab 'n go vantage valve to be sheared from the cylinder.Due to the force of the oxygen release from the cylinder, it projected across the room and hit the door frame.The grab 'n go vantage oxygen valve remained at the foot of the bed.No one was injured in this incident.Because this is a heavy duty bed, a significant force was applied to the cylinder valve causing the valve to be sheared off.The grab 'n go vantage is a class i valve integrated pressure regulating device, which is installed onto an aluminum high pressure medical oxygen usp cylinder.

• Brand Name: PRAXAIR GRAB 'N GO VANTAGE
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): PRAXAIR HEALTHCARE SERVICES (SPEC DEVELOPER); 175 east park drive; tonawanda NY 14150
• Manufacturer (Section G): PRAXAIR HEALTHCARE SERVICES (SPEC DEVELOPER); 175 east park drive; tonawanda NY 14150
• Manufacturer Contact: michael skrjanc ; 175 east park drive; tonawanda, NY 14150 ; 3309493324
• MDR Report Key: 5813543
• MDR Text Key: 50172835
• Report Number: 1000448358-2016-00002
• 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: Respiratory Therapist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: PRX-9500
• Device Catalogue Number: OX MAEGNGVNTG
• Device Lot Number: O70567612043 (GAS)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• 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
• Patient Weight: 227