MAUDE Adverse Event Report: PARKER HANNIFIN, PRECISION FLUIDICS DIVISION, PORTER MXR 3000 FLOWMETER WITH E-STAND MOBILE CART; GAS MACHINE - ANESTHESIA

Model Number 2045-3

Device Problems Fire (1245); Occlusion Within Device (1423); Device Stops Intermittently (1599); Flare or Flash (2942)

Patient Problem Burn(s) (1757)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

The next day we received word from the biomed that he had minor burns on his arm from trying to close the tank.He heard a loud pop then the regulator just blew apart and was on fire.He sent pictures and the oxygen regulator picture shows that the entire top of the regulator is blown off.Other pictures show evidence of parts involved in the flames.The devices were shipped from precision fluidics on 10/30/2013.The biomed further reports that the burns are healing well, he is following treatment instructions from a doctor at the hospital, and he is back to work.Precision fluidics has received the e-block assembly of the cart for our analysis.Pictures of the subject regulator have been taken and the assembly is secured at the (b)(4).Manufacturing facility pending our detailed investigations.We have no further analysis of the incident, but will conduct a complaint analysis and produce necessary medical and fda internal documentation.We have no records of any similar incidents of fire or regulators blowing up involving our products, particularly, the regulator models we have used from our supplier for over 13 years.Successfully in the application.

Event Description

A distributor clinical product specialist was a "phone witness" to an event at a hospital user facility, while on the phone to troubleshoot a porter mxr nitrous oxide / oxygen flowmeter mounted to a porter 2045-3 model e-stand mobile cart.The user facility biomed technician had removed the devices from service and had a complaint that the oxygen flow stopped, and he said the o2 cylinder gauge would read correctly, however shortly after the flow had started, the mobile cart oxygen regulator would sputter and stop flow to the flowmeter.During the call, the biomed technician turned on the oxygen tank valve and immediately the specialist heard screaming.He came back on line shortly and said the oxygen regulator had a problem and "just blew up." he had turned off the oxygen tank valve and had burned his arm in the process.No patients or doctors were involved, as the device and cart were out of service and the biomed technician was the only one injured.

• Brand Name: PORTER MXR 3000 FLOWMETER WITH E-STAND MOBILE CART
• Type of Device: GAS MACHINE - ANESTHESIA
• Manufacturer (Section D): PARKER HANNIFIN, PRECISION FLUIDICS DIVISION,; 245 township line road; hatfield PA 19440 0907
• Manufacturer (Section G): PARKER HANNIFIN, PRECISION FLUIDICS DIVISION; 245 e. township line road; hatfield PA 19440
• Manufacturer Contact: stephen loeffler ; 245 e. township line road; hatfield, PA 19440 ; 2156608123
• MDR Report Key: 6984809
• MDR Text Key: 90656610
• Report Number: 2518157-2017-00001
• Device Sequence Number: 0
• Product Code: BSZ
• Reporter Country Code: US
• PMA/PMN Number: K923781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2045-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention