MAUDE Adverse Event Report: RESPIRONICS SYSTEM ONE BIPAP; VENTILATORY SUPPORT SYSTEM

Model Number 760P

Device Problems Use of Incorrect Control/Treatment Settings (1126); Moisture or Humidity Problem (2986); Pressure Problem (3012)

Patient Problem Respiratory Distress (2045)

Event Date 09/12/2014

Event Type  Injury  

Event Description

I received a new system one respironics cpap machine on (b)(6), when i went to use it, it did not work like my old machine did; it did not provide enough pressure.I contacted respironics which referred me back to my provider, i then returned on wednesday (b)(6) to have the settings "adjusted" which again did not help, the machine was still not working properly.I then returned on friday (b)(6) to once again have my machine "adjusted" which showed a slight improvement.However, this created a new problem of water inside my mask, literally dripping and running out of it, my tubing was also full of water, i had to get up three times during the night to drain water out of my tubing.This is causing the potential for me to drown in my own bed because this machine does not work properly and respironics will not help, nor will they teach my provider to fix or adjust the machine properly.

• Brand Name: SYSTEM ONE BIPAP
• Type of Device: VENTILATORY SUPPORT SYSTEM
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 4109222
• MDR Text Key: 18572379
• Report Number: MW5038248
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 760P
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 83