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

Model Number DREAMSTATION AUTO-BIPAP

Device Problems Use of Incorrect Control/Treatment Settings (1126); Product Quality Problem (1506)

Patient Problem Dyspnea (1816)

Event Date 06/30/2022

Event Type  Injury  

Event Description

Patient received replacement bilevel pap device for machine recalled by philips respironics.It was dispensed without being programmed to the ordered settings (left on default settings rather than per orders).I have seen this happen in multiple other cases with the respironics replacement devices.In this case, the patient is experiencing more periodic breathing as a result.Pap download shows an increase in % of periodic breathing from 4.1% of night to 10.4% after the patient started using the replacement machine, which was not programmed to the patient's ordered settings.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION AUTO BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14934503
• MDR Text Key: 295428869
• Report Number: MW5110683
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION AUTO-BIPAP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White