MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS RESPIRONICS DREAMSTATION 1 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAM STATION 1

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problems Arrhythmia (1721); Fatigue (1849); Headache (1880); Visual Impairment (2138); Burning Sensation (2146); Sleep Dysfunction (2517)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Philips dreamstation recalled devices was never replaced and i had to continue with treatment.I started waking up in the middle of the night with extreme sinus burning for hours in middle of the night intermittently and had to stop using my cpap machine.I started experiencing degradation of eyesight and extreme head-aches and sleepiness during the daytime after discontinued use of the machine and in increased occurrences of cardiac arrhythmia (premature ventricle contractions).Philips was dragging their feet on replacement machines for 2 years and due continued degradation of my health, i was forced to buy a new device at my own expense while i wait.Philips recently sent me 2x refurbished and discontinued model devices as replacements for recalled devices and neither of these previously used machines work and both replacement devices are defective.I called philips and demanded they sent me new generation devices that they have been replacing for other patients and they refused.At this time i am still out of pocket for thousands of dollars of machines that don't work and had to spend my own money to buy a device to use while i await recall replacements.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION 1 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16379636
• MDR Text Key: 309670402
• Report Number: MW5114946
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DREAM STATION 1
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White