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

Device Problem Output Problem (3005)

Patient Problems Headache (1880); Sleep Dysfunction (2517)

Event Date 03/25/2023

Event Type  Injury  

Event Description

Numerous (about 8) requests have been made since november 2022 to dme supplier performance medical to provide parts for the face mask used with my cpap machine and there is no response from this supplier.Rather, i was told it was ordered and the shipper indicated "in process".I am unable to use my cpap machine effectively, therefore, and am suffering headaches and sleep deprivation symptoms.I also brought to their attention that my cpc machine was turning on and off intermittently on its own.It's possible i need a new machine.This was ignored by the performance medical representative, (b)(6).

• Brand Name: DREAMSTATION 2 AUTO ADVANCED CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16631548
• MDR Text Key: 312329118
• Report Number: MW5116057
• 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: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLOPIDINE; CLONIDINE; HYDROCHOLORTHIAZIDE; LEVOTHYROXINE
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White