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

Model Number MTR-800

Device Problems Burst Container or Vessel (1074); Component Falling (1105); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The subject cylinder system (ie, valve integrated pressure regulator (vipr) attached to e-size aluminum cylinder), hereafter referred to as the "unit", was on the top tier of a cylinder filling rack at the fill plant.After completion of the filling process, the cylinder was filled with oxygen and was disconnected from the supply header.The fill plant operator was pulling a unit off the rack next to the subject unit, when the subject unit slid off the inclined rack, vipr end down, and fell about 2 feet striking the concrete floor.The operator reported seeing a "flash".The aluminum cylinder ruptured and the vipr also separated from the cylinder.The event damaged the fill rack and several adjacent units.The operator was standing about 3 feet from the subject unit when it hit the floor.It was reported that the operator incurred minor injuries and was cleared to return to work the next work day.

Manufacturer Narrative

Distribution records indicate the subject product was shipped from western on (b)(4) 2010 on an oxytote regulator, or vipr, only.The product was subsequently attached to the aluminum cylinder by the customer.The reporter indicated that the aluminum cylinder was being forwarded to the cylinder manufacturer for analysis.The reporter indicated that he vipr (valve integrated pressure regulator) would be returned to western for evaluation.Receipt of the vipr at western is still pending at this time.The reporter remarked that he operator appeared to be working too fast, was rushed, and was not paying attention.Pictures were supplied by the reporter to western.Pictures show the cylinder had ruptured into 3 pieces.The external surface of the vipr exhibited soot damage and the gauge was bent and exhibited heat damage.The reported "flash", visible soot and heat damage are indicative of an ignition event.

• Brand Name: OXYTOTE PORTABLE OXYGEN REGULATOR
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; 875 bassett rd.; westlake OH 44145 114
• Manufacturer Contact: david simo ; 875 bassett rd.; westlake, OH 44145-1142 ; 4408712160
• MDR Report Key: 3786968
• MDR Text Key: 4443651
• Report Number: 1526809-2014-00003
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MTR-800
• Device Catalogue Number: MTR-800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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