MAUDE Adverse Event Report: WESTERN/SCOTT FETZER CO. WESTERN MEDICA MEDICAL OXYGEN PRESET REGULATOR

Model Number M1-540-P

Device Problems Display or Visual Feedback Problem (1184); Device Inoperable (1663); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Medical Gas Supply Problem (2985)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Brain Injury (2219)

Event Date 07/30/2012

Event Type  Injury  

Event Description

According to information provided by the initial reporter: oxygen regulator gauge showed approximately 1000 lbs 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 800-900 lbs of pressure.Plaintiffs allege cardiac arrest and brain injury.(b)(4).

Manufacturer Narrative

The m1-540-p is a single stage, preset oxygen regulator with maximum inlet pressure of 3000 psi.The outlet pressure is factory preset to deliver outlet pressure when the supply (i.E., tank) is turned on (i.E.Delivers 50-56 psi at a supply pressure of 2000-2200 psi).The model has one, 2" diameter gauge (i.E., bourdon tube gas pressure gauge), which displays the gas pressure supplied to the regulator.The customer reported that the "tank was empty despite regulator gauge reflecting approximately 800-900 lbs of pressure." records indicate the subject device shipped from western to the customer on (b)(6) 2011.The subject device was not returned to western for evaluation, but is being retained by the customer's attorneys.Without physical evaluation, the actual cause of the alleged discrepancy cannot be determined.

• Brand Name: WESTERN MEDICA MEDICAL OXYGEN PRESET REGULATOR
• Manufacturer (Section D): WESTERN/SCOTT FETZER CO.; westlake OH
• Manufacturer Contact: david simo ; 875 bassett rd.; westlake, OH 44145-1196 ; 4408712160
• MDR Report Key: 3753560
• MDR Text Key: 4549874
• Report Number: 1526809-2014-00001
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2013,12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1-540-P
• Device Catalogue Number: M1-540-P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/30/2012
• Event Location: Other
• Date Report to Manufacturer: 12/04/2013
• Date Manufacturer Received: 12/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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
• Patient Outcome(s): Disability
• Patient Age: 20 MO