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

Model Number MTS-503

Device Problem Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

As reported to western, an operator in a cylinder fill plant was unloading oxygen filled cylinder systems (i.E., valve integrated pressure regulator (vipr) attached to an aluminum cylinder) from a filling rack and placing them into a cylinder cart.Upon setting a cylinder system into the cart, the cylinder exploded, rupturing the aluminum cylinder into 4 pieces and resulting in the separation of the vipr from the cylinder.The explosion of the subject system in the cart caused a reaction with 4 other proximate cylinder systems in the cart causing the viprs to separate from those cylinders as well.It was reported that the operator incurred minor injuries, was treated at a medical facility, and released that same day.It was also reported that as a result of the incident, the operator is scheduled for further examination for a problem with his hearing and vision and for soreness walking.

Manufacturer Narrative

Western has initiated a voluntary recall of subject portable oxygen systems (i.E., valve integrated pressure regulatory (vipr) mounted on an (b)(4) cylinder) independent lab investigation results indicate that material (b)(4) o-ring seal used between the vipr and the aluminum cylinder is a (b)(4).There have been (2) previous ignition events reports to western involving oxytote units, which were reported on medwatch report number 1526809-2014-00003 and medwatch report number 1526809-2014-00004.Western has requested that the subject system (vipr and cylinder) be sent by the customer to an independent third party laboratory for analysis.

• 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: 4418524
• MDR Text Key: 5418786
• Report Number: 1526809-2015-00001
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MTS-503
• Device Catalogue Number: MTS-503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 1526809-12/31/14-002R
• Patient Sequence Number: 1