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

Device Problem Nonstandard Device (1420)

Patient Problems Bronchitis (1752); Dyspnea (1816); Respiratory Tract Infection (2420); Cough (4457)

Event Date 11/16/2020

Event Type  Injury  

Event Description

I used the recalled cpap(continuous positive airway pressure) that was recalled.I have had numerous respiratory infections lasting months.I have been prescribed three and four antibiotics and steroids.With lingering cough and being winded, i am concerned if this come from the recall of my philips cpap machine.I've had numerous chest x-rays and have taken way too many antibiotics, steroids and inhalers.I have had bronchitis or respiratory infections off and on for several years.I am winded at times.This shouldn't be happening.

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16545591
• MDR Text Key: 311389800
• Report Number: MW5115733
• 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: 03/11/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2023
• Patient Sequence Number: 1
• Treatment: CALCIUM WITH D. ; LEVOTHYROXINE; LEXAPRO; PLAVIX; PROAIR; PROTONIX; SINGULAIR
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White