FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

A-OX A-OX PORTABLE OXYGEN TANK (E CYLINDER)   back to search results
Model Number E CYLINDER
Patient Outcome  Other;
Event Description

Person was attaching regulator to portable oxygen tank. In process, the plastic o-ring came off which he reapplied with the regulator. He tightened the regulator, turned it on and there was a release of oxygen. He loosened the regulator, retightened it and the leak continued. On his third attempt to attach the regulator, a loud booming noise occurred and flames shot out of the seal area. He turned off the tank immediately. His hair was singed but no injury occurred. The seal area and regulator attachment both melted.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameA-OX
Type of DevicePORTABLE OXYGEN TANK (E CYLINDER)
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
A-OX
4100 north cliff
sioux falls SD 57104
Device Event Key193127
MDR Report Key198803
Event Key186806
Report NumberMW1015046
Device Sequence Number1
Product CodeCAN
Report Source Voluntary
Report Date 11/18/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberE CYLINDER
Device LOT Number1015989989435
OTHER Device ID Number1CC-3AA2015 SPUN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/16/1998
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH