MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Moisture Damage (1405); Nonstandard Device (1420); Product Quality Problem (1506); Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Fatigue (1849); Sleep Dysfunction (2517)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Patient called to report an issue with her replacement cpap device she received after her first one was recalled by philips respironics.Patient stated her first dreamstation cpap device was recalled, and she received a replacement dreamstation 2 auto cpap device about two months ago.Patient stated after a month of using the new device, she woke in the middle of the night with water inside the mask where her nose and mouth are.Patient said it then happened a second time where she woke up to water in the mask.Patient also stated the water reservoir makes a lot of noise and the noise comes through the mask.Patient stated she is very tired, and this has disrupted her sleep, she wakes in the middle of the night worrying she is going to choke on water getting into her mask.Patient stated she tried calling philips respironics, but she just gets put on hold and hung up on.

• Brand Name: DREAMSTATION 2 AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13059942
• MDR Text Key: 282646028
• Report Number: MW5106205
• Device Sequence Number: 2
• 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: 12/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female