MAUDE Adverse Event Report: WESTERN MEDICAL GREEN REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 01/22/2014

Event Type  No Answer Provided  

Event Description

Post-op patient connected to portable medical gas tank for transport.Oxygen saturation dropped.Patient cardiac arrested.Found that pt was connected to a co2 tank.Patient was successfully resuscitated.The co2 tank had a green plastic adapter (cone shaped adapter) on the regulator nozzle.Green adaptors indicate oxygen.

• Brand Name: GREEN REGULATOR
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): WESTERN MEDICAL; 1001 n. tustin ave,; santa ana CA 92705
• MDR Report Key: 3624023
• MDR Text Key: 19919541
• Report Number: 3624023
• Device Sequence Number: 2
• Product Code: CAN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WORD OHIO STAMPED INTO THE METAL. TANK; REGULATOR MFG: WESTERN MEDICAL, WESTLAKE, OH ; RADNOR, PA.; CO2 TANK MFG: TANK MFG NAME UNKNOWN. TANK HAS THE; NO OTHER THERAPIES; DISTRIBUTOR: AIRGAS PURITAN MEDICAL/ AIRGAS USA,
• Patient Age: 80 YR