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

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 12/01/2021

Event Type  Injury  

Event Description

Cpap machine recalled and medical provider and phillips has failed to replace or repair or provide alternative treatment.Have experienced episodes of decrease lung function and constant upper respiratory symptoms, copd, chronic cough and shortness of breath.

• Brand Name: PHILIPS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16573833
• MDR Text Key: 311700153
• Report Number: MW5115836
• 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: 03/15/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White