MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problems Breast Cancer (1759); Cough (4457); Respiratory Insufficiency (4462); Wheezing (4463); Subcutaneous Nodule (4548)

Event Type  Injury  

Event Description

Worsening lung problems coughing wheezing shortness of breath ct (computed tomography) and x-ray issues in lungs, lung nodules, breast cancer.

• Brand Name: PHILIPS RESPIRONICS CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17745582
• MDR Text Key: 323526810
• Report Number: MW5145632
• 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: 09/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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
• Patient Outcome(s): Other; Disability
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White