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

Device Problems Nonstandard Device (1420); Use of Device Problem (1670)

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/10/2019

Event Type  Death  

Event Description

I'm reporting this on behalf of my father who used a confirmed recall # phillips respironics bipap system from (b)(6) 2011 through (b)(6) 2017.Prior to this he had no pulmonary issues other than sleep apnea.In 2017 he was diagnosed with pneumonia and established care with a pulmonologist with ct scan indicating possible interstitial lung disease.He also developed some swallowing challenges with aspiration confirmed by swallow study and worked briefly with a speech therapist on swallow strategies to decrease aspiration risk.On (b)(6) 2019 was hospitalized with extreme shortness of breath and died on (b)(6) 2019 with cause of death identified as interstitial lung disease.

• Brand Name: RESPIRONICS BIPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17192118
• MDR Text Key: 317844766
• Report Number: MW5118721
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/19/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Patient Sequence Number: 1
• Treatment: MY DAD TOOK SEVERAL MEDICATIONS FOR SEIZURE MANAGEMENT GIVEN HIS EPILEPSY. I DON'T HAVE LIST, BUT COULD OBTAIN IF NEEDED.
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White