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

Model Number DSX700H11

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Cyst(s) (1800); Pneumonia (2011); Fungal Infection (2419)

Event Date 12/05/2019

Event Type  Injury  

Event Description

Started wearing philips respironics bipap in spring of 2018.A year later i acquired valley fever, chronic pneumonias requiring hospitalization, and now blood labs showing positive antibodies for lupus.All of these progressing diseases started after wearing the philips respironics bipap, which is now in recall.My device's serial number is on the recall list.On (b)(6) 2021.Lung biopsy confirmed coccidioidomycosis (valley fever) started growing again.Currently taking fluconazole for valley fever.My lungs have not been the same since using the philips respironics bipap, that is now recalled, as per my bipap's serial number.Worked as a nurse for 15 years.Now on disability for rare disease sacral tarlov cysts-symptomatic.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS BIPAP MEDICAL DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12916808
• MDR Text Key: 281689825
• Report Number: MW5105721
• 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: 11/29/2021

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
• Device Model Number: DSX700H11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Patient Sequence Number: 1
• Treatment: CALCIUMD3; FLUCONAZOLE (VALLEY FEVER); HYDROXYCHLOROQUINE (LUPUS); LEVOTHYROXINE (HASHIMOTOS THYROIDITIS); LIDOCAINE 5% PATCHES (TARLOV CYSTS); OMEPRAZOLE (GERD); SUPER B VIT; VIT C; WOMANS ONE A DAY
• Patient Outcome(s): Disability; Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White