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

Patient Problems Pain (1994); Sleep Dysfunction (2517); Unspecified Gastrointestinal Problem (4491); Skin Burning Sensation (4540)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

This machine that replaced my first always had a horrible squeak sound.Then in november received error message humidifier didn't work, then it did, then it didn't.Now i have cold, dry air and it causes horrible stomach pain after i have it on a couple of hours, i wake with burping and passing gas.My first machine was wonderful, this one is awful.I touched the power supply in the night and it was so hot i thought it burned my hand.I now have worse sleep than ever, even not wearing it it's like i'm traumatized to wake every couple of hours because that is what it has done to me.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 18922260
• MDR Text Key: 338110773
• Report Number: MW5152920
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE. ; METOPROLOL.
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander, White