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

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Philips continuous positive airway pressure was recalled.A replacement was sent on (b)(6) 2022.It stopped working (b)(6) 2022.We have spoken several times to medstar and philips to solve the issue.To date, my sister is without her needed medical equipment.Her medical condition is worse.We need help.

• Brand Name: PHILIPS CONTINUOUS POSITIVE AIRWAY PRESSURE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16043121
• MDR Text Key: 306245821
• Report Number: MW5113959
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN, HYDROCHLOROTHIAZIDE.; CONTINUOUS POSITIVE AIRWAY PRESSURE.; MULTIVITAMINS.
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American