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

Model Number DSX700H11C

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682); Pressure Problem (3012)

Patient Problems Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Date 10/30/2017

Event Type  Injury  

Event Description

Received my dream station in (b)(6) 2017.Had surgery for an unrelated problem in (b)(6) 2017.I had a large hiatal hernia that had pulled over half of my stomach through the diaphragm and it was stuck inside my chest cavity.Following that surgery i noted my abdomen was inflated and bloated from the air from my bipap.Checked with my pulmonologist office who agreed to reduce my pressure level.Continued with same problem and air pressure was reduced once again.In (b)(6) 2020 i had emergency surgery due to a new hernia on my recent surgical repair along with a bowel obstruction.The surgeon felt that the pressure from the bipap contributed to the bowel becoming stuck in my new hernia.Following this occurring i spoke again with my pulmonologist who further reduced the pressure and stated he had never heard of anything like this.My pressure on the dream station was reduced to a non therapeutic level for my sleep apnea but it greatly reduced the bloating i was experiencing.Now with the recent recall of the dream station, i have discontinued the use of that device.I have my older machine, a resmed that i am using now with the higher pressure setting.I am not experiencing the abdominal bloating that has been occurring.I have copies of the medical reports from the hospitalizations if needed.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12239018
• MDR Text Key: 264782622
• Report Number: MW5102804
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700H11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 69 YR
• Patient Weight: 109