MAUDE Adverse Event Report: WESTERN MEDICA WESTERN MEDICA; OXYGEN REGULATOR

Model Number MI-540-P

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219)

Event Date 07/30/2012

Event Type  Injury  

Event Description

Oxygen regulator gauge showed approximately 1000lbs of pressure in oxygen tank before use.During use, flow ceased and alternate tank was utilized.Assessment of oxygen tank and gauge after event revealed tank was empty despite regulator gauge reflecting approximately 800-900lbs of pressure.Plaintiffs allege cardiac arrest and brain surgery.Please refer mfr report # 1526809-2014-00001.

• Brand Name: WESTERN MEDICA
• Type of Device: OXYGEN REGULATOR
• Manufacturer (Section D): WESTERN MEDICA; westlake OH
• MDR Report Key: 3753541
• MDR Text Key: 4550385
• Report Number: 3753541
• Device Sequence Number: 1
• Product Code: CAN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI-540-P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2012
• Event Location: Other
• Date Report to Manufacturer: 12/04/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 20 MO