MAUDE Adverse Event Report: WESTERN/SCOTT FETZER CO. OXYTOTE PORTABLE OXYGEN SYSTEM; REGULATOR, PRESSURE, GAS CYLINDER

Model Number VLB-603H; VLB-600L

Device Problem Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2014

Event Type  Death  

Event Description

As reported to western, an employee was refilling a 23 cubic foot aluminum luxfer cylinder with oxygen and bumped it on something.After that, it exploded and resulted in the death of the employee.It was reported that the cylinder was manufactured in 2012.

Manufacturer Narrative

The original report alleges an oxytote portable oxygen system, consisting of a valve integrated pressure regulator (or vipr) mounted to an aluminum oxygen cylinder, which is used for oxygen therapy.At this time, no product was returned for evaluation, therefore, positive identification of the subject device has not yet been established.

• Brand Name: OXYTOTE PORTABLE OXYGEN SYSTEM
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; 875 bassett rd.; westlake OH 44145
• Manufacturer Contact: david simo ; 875 bassett rd.; westlake, OH 44145 ; 4408712160
• MDR Report Key: 4129360
• MDR Text Key: 4948164
• Report Number: 1526809-2014-00004
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: VLB-603H; VLB-600L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death