MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSVADVANCED

Model Number 1042907

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  malfunction  

Event Description

The manufacturer received information that a thermal event occurred in an end user's home, and that a "philips respironics bipap ventilator machine" is alleged to have caused or contributed to the event.There was no patient harm or injury reported.The model number and serial number of the device alleged to have been involved in the reported event have not been confirmed, and these numbers may change on subsequent reports.The manufacturer's investigation is on-going.A follow up report will be filed upon completion of the manufacturer's investigation.

Manufacturer Narrative

The manufacturer has made numerous requests for the return of the device and for additional information.To date, no product has been returned, and no further information has been received.The manufacturer is unable to confirm the allegation that a philips respironics device caused or contributed to a thermal event in an end user's home.There is no allegation of patient harm or injury.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: BIPAP AUTOSVADVANCED
• Type of Device: BIPAP AUTOSVADVANCED
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 5302778
• MDR Text Key: 34334188
• Report Number: 2518422-2015-04193
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1042907
• Device Catalogue Number: 1042907
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• 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