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

Patient Problem Sleep Dysfunction (2517)

Event Date 03/01/2024

Event Type  Injury  

Event Description

Reporter called to inform the fda about his dreamstation 1 continuous positive airway pressure (cpap) machine.He owns two dreamstation devices located in two separate locations.The one that he is presently using was initially recalled and then refurbished and replaced.When first receiving the refurbished cpap, the machine was so loud and noisy that reporter stated he was not able to sleep.In the past 3 to 4 months, the machine has been replaced three times due to machine quality issues related to it being too noisy to sleep.With his fourth cpap machine (present one), respironics instructed reporter - over the phone - to make changes to the settings, giving him step-by-step codes to get into the software system in an attempt to quiet the machine.Reporter learned that settings are only supposed to be changed by the provider yet, respironics had him try to change the settings.Now the settings are all "jacked up" and the machine is not functional.Reporter states that he has 40-50 back-and-forth email correspondences to replace the machine due to settings all messed up per their instructions.They are unwilling to assist in replacement.Reporter states that respironics gave proprietary information to a non-medical provider to try and resolve a machine issue that was their responsibility.This can be a safety hazard to the general public who uses the device.Reference reports: mw5153078, mw5153079, mw5153080.

• Brand Name: DREAMSTATION 1 CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18968993
• MDR Text Key: 338623483
• Report Number: MW5153081
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male