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

Device Problems Alarm Not Visible (1022); Decrease in Pressure (1490); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/28/2021

Event Type  Injury  

Event Description

Transient spo2 desat to 83; philips respironics brand bipap autosv (systemone 60 series) in operation for nearly a year, then began to make a constant hissing sound and did not deliver sufficient pressure to assist in respiration.However, no pressure or other alarms (audible or visible) resulted and automated reports provided to the prescribing physician did not indicate any issues.Pt awoke every 90 to 115 minutes gasping for breath for three nights.On the fourth night pt awoke at 02:30 with spo2 of 83.The dme supplier provided a loaner machine and the original was returned to philips.The dme supplier then advised that philips had agreed to replace the machine rather than repair it.As other similar reports have been filed in maude previously, i recommend that philips evaluate, among other possible causes, the possible degradation of the humidifier chamber seal over time from regular use and/or cleaning (and the impact of inspiration/expiration on the measured pressures following such degradation, if any) and the potential impact on the pressure sensors of extreme pressure irregularities potentially arising from the use of pressurized/contained ozone based cleansing machines without appropriate pressure relief valves or with faulty pressure relief valves.Fda safety report id# (b)(4).

• Brand Name: BIPAP AUTOSV (DREAM STATION)
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 11421524
• MDR Text Key: 238373975
• Report Number: MW5099793
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/02/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 90