MAUDE Adverse Event Report: PRAXAIR GRAB-N-GO PORTABLE OXYGEN CYLINDER

Model Number CATALINA II

Device Problem Burst Container or Vessel (1074)

Patient Problem Burn(s) (1757)

Event Date 04/10/2014

Event Type  Injury  

Event Description

A portable oxygen tank exploded in pt room (b)(6) which is a telemetry unit at approx 8:45 pm on (b)(6).The employee working in the room sustained injuries and was transferred to a regional burn unit via air transport where she remains.The pt in the room did not sustain injury.The visitor in the room sustained minor injuries and was treated in the emergency department and released.There were three pt rooms with significant damage.Seventeen pts required re-location to other units within the hosp.

• Brand Name: GRAB-N-GO PORTABLE OXYGEN CYLINDER
• Type of Device: GRAB-N-GO PORTABLE OXYGEN CYLINDER
• Manufacturer (Section D): PRAXAIR; danbury CT 06810
• MDR Report Key: 3776066
• MDR Text Key: 4446428
• Report Number: MW5035798
• Device Sequence Number: 1
• Product Code: CAN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CATALINA II
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 30 YR