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

Device Problems Material Discolored (1170); Nonstandard Device (1420); Material Deformation (2976)

Patient Problems Dyspnea (1816); Headache (1880)

Event Type  Injury  

Event Description

I was part of the philips recall.After a good six or more months from when my cpap was recalled, i received a new one.After using this one for a few months i am now noticing the pink coating in the tube and water container from the foam, it was recalled for.I have had constant headaches and breathing issues which i figured was just stress and my asthma but now seeing the pink color again i'm wondering if it's not from the machine.I have a heart condition already and need the device to help with my sleep apnea.Please advise what i need to do next, i'm not happy and my health is being affected by it.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 15632905
• MDR Text Key: 302077760
• Report Number: MW5112725
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: I'M ON A LOT OF MEDS
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White