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

Patient Problems Apnea (1720); Arrhythmia (1721)

Event Date 07/09/2021

Event Type  malfunction  

Event Description

I was notified two and a half years ago about a recall on my philips cpap and was told to complete registration information online, including the serial # of my device.I completed this promptly, but kept using my cpap which was still functioning.I heard nothing back from phillips.Two months ago, my cpap broke.When i went to lincare, the local provider for the cpap, they said they could not fix the machine due to the recall and that they could not replace it because i was not due for another unit yet.I contacted philips at this point to see where my replacement was.They had changed systems, lost my entire file from earlier, and i had to start a file with them all over again.Over these months, i have had to see my sleep doctor to get a new prescription for my cpap, have her submit new paperwork, and call philips repeatedly, every other week, to check on the status of my replacement machine.On every call, i am given conflicting information.In addition, i receive emails with faulty and/or contradictory statements.For example, today one person told me philips did not have my prescription yet.I was forwarded to another person who told me my machine had been shipped.Didn't i have it yet? information from philips is never consistent, never makes sense.I have been in contact with my doctor, who tells me her office has the same repeated problems with philips.I am 80 years old.I've recently worn a heart monitor to collect data on my heart's function.It reported fibrillation 100% of the time.This device is critical for my health and well-being.How can i get help? overall ahi(apnea-hypopnea index) of 54.5; central apnea index of 47.6 with spo2 nadir = 74%.Device recall.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 18436988
• MDR Text Key: 331906385
• Report Number: MW5149736
• 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: Patient
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN.; LISINOPRIL .; METOPROLOL .; VITAMIN D .; XARELTO .
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White