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

Model Number DSX500H11C

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pulmonary Edema (2020); Sore Throat (2396); Low Oxygen Saturation (2477)

Event Date 07/27/2021

Event Type  Injury  

Event Description

I've been using philips respironics cpap machine (dream station) since 2018.However around (b)(6) 2020, i noticed throat irritation, chest pressure and shortness of breath.I took cough medication and used albuterol to clear my airway.On (b)(6) of this year i went to my doctor to discuss my shortness of breath.The nurse checked my oxygen saturation and it was only 87%.It was dropping while the doctor was examining me so he called the attending doctor to see me and they decided to send me to the emergency room.I was immediately given oxygen.The er doctor ordered tests, cbc, chest x-ray, 2d echo.They found my lungs was full of fluids and inflamed.I stayed in the hospital for one night and the next morning i did a six minutes walk and the doctor said from now on, i will needing supplemental oxygen.Philips is now recalling the cpap machine i was using because the foam used in the machine may have degraded into particles which could entered in the device's air pathway into my lungs.My life has been abruptly changed and i'm no longer able to do a lot of things because i'm using oxygen machine.Fda safety report id# (b)(4).

• Brand Name: CPAP MACHINE DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12482241
• MDR Text Key: 272483463
• Report Number: MW5104035
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 65 YR
• Patient Weight: 68