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

Model Number DSX700H11C

Device Problems Fire (1245); Smoking (1585)

Patient Problem Sore Throat (2396)

Event Date 09/21/2021

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of a thermal event on a dreamstation auto bipap.The user reported that the machine caught fire at the plug in on the machine.The user reported burning, smoke, electrical odor and seeing a flame.There was no report of serious patient harm or injury, user reported nasal/throat irritation or soreness.There was no medical intervention.The device with power accessories has not yet been returned for investigation.The investigation is on-going.A follow up final will be submitted once the investigation is complete.

Manufacturer Narrative

Correction on initial report should be september 21, 2021.The manufacturer has not received the devices for investigation.Despite multiple requests, no device has been returned.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 15017686
• MDR Text Key: 295909103
• Report Number: 2518422-2022-60218
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2019
• 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
• Treatment: HUMIDIFIER, NO SN PROVIDED
• Patient Sex: Male