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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Lymphoma (3263); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2022

Event Type  Injury  

Event Description

I had been having shortness of breath problems that began as mild in early 2021.After undergoing several cardiac and pulmonary tests including an angiography, nothing was revealed as the cause of the sob.In (b)(6) 2022, i began experiencing more frequent sob episodes.In (b)(6) 2022, the progression of deterioration became rapid.By the last half of (b)(6) each week i saw a significant decline in my ability to breathe with any kind of effort.On (b)(6) 2022, i was forced to retire from my part time job because i could not perform the activities required of me as a physical therapist.By the middle of (b)(6), i could not walk 10 feet without becoming sob and requiring to stop, i could not lay flat, and it took me a prolonged time to do simple self-care activities such as showering and dressing.On (b)(6) 2022, i was hospitalized with l lung pleurisy and 3 liters of fluid was drained from that lung.Additional thoracentesis were required from (b)(6) 2022.Tests on the fluid removed at the time of the (b)(6) thoracentesis revealed possible cancer cells.At the end of (b)(6), additional tests including ct and pet scans confirmed that i have an uncurable non-hodgkin's lymphoma.It began in the lung lymph and had spread to other lymph nodes in the upper and lower body segments.In (b)(6) 2022, i began a chemo treatment series.That initial series has been completed and will be followed by a less frequent chemo treatment administration until it is no longer effective.

• Brand Name: PHILIPS RESPIRONICS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 16832903
• MDR Text Key: 314294375
• Report Number: MW5117113
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White