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

Patient Problems Apnea (1720); Sleep Dysfunction (2517)

Event Date 05/07/2023

Event Type  Injury  

Event Description

This 88 year old man with obstructive sleep apnea and treatment-emergent central (complex) sleep apnea was treated with an adaptive servo-ventilation (asv) device.The device detected frequent vibratory snores and responded with inappropriate pressures.This occurred on multiple nights.Erroneous detection of "vibratory snores" and resultant inappropriate increase in machine pressure is a known defect in respironics devices.Higher pressures risk exacerbating the central apneas that are part of this patient's diagnosis.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 19212039
• MDR Text Key: 341489897
• Report Number: MW5154410
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 88 YR
• Patient Sex: Male