MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP PRO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX600T11C

Device Problems Fire (1245); Off-Label Use (1494); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a dreamstation bipap pro located under a nightstand and not plugged in caught on fire.The flames were extinguished.The power cord was melted to the top of the device.There was no harm or injury to the user.The device has been received by the manufacturer but the investigation is still on-going.A follow up final report will be submitted once the investigation is complete.

Manufacturer Narrative

The manufacturer previously reported that a user experienced a thermal event with his dreamstation bipap pro device.The user stated the device caught fire while unplugged and the power cord melted to the top of the device.There was no patient harm or injury reported.The device was returned to the manufacturer's product investigation laboratory and the customers complaint was confirmed.There was evidence of extensive thermal damage to the exterior of the device causing a void, with an ac power cord partially melted to the enclosure.The ac power cord returned with the device was not a philips approved cord.The manufacturer concludes the thermal damage occurred as a result of an unknown external source and user misuse and was not due to a malfunction of the device.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: DREAMSTATION BIPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13191445
• MDR Text Key: 283399072
• Report Number: 2518422-2022-00228
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX600T11C
• Device Catalogue Number: DSX600T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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 Age: 85 YR
• Patient Sex: Female