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

Model Number DSX700T11C

Device Problems Degraded (1153); Fire (1245); Device Emits Odor (1425)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging of a thermal event to a dreamstation auto bipap device.The user alleges device has burning smell and device/power cord or supply caught fire.There was no report of patient harm or injury.The manufacturer has not received the device 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.

Manufacturer Narrative

The manufacturer previously reported a thermal event to a dreamstation auto bipap device.The user alleged device had a burning smell and device/power cord or supply caught fire.There was no report of patient harm or injury.The manufacturer received additional information from user stating lungs are in pain.There was no report of serious patient harm or injury and no report of medical intervention.The manufacturer has not received the device 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: 14988607
• MDR Text Key: 295714361
• Report Number: 2518422-2022-59251
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1