MAUDE Adverse Event Report: PHILLIPS RESPIRONICS INC. PHILLIPS RESPERONICS BI-PAP; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Device Problem Nonstandard Device (1420)

Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Fungal Infection (2419)

Event Date 07/07/2021

Event Type  Injury  

Event Description

I had a bronchoscopy done for pulmonary ariel hypertension at (b)(6) in (b)(6) 2021.The procedure determined that i have a lung fungus infection in my chest.The next morning i was unresponsive and taken to (b)(6).An ultra sound scan was done.It was determined that my blood pressure had bottomed out.Had to be removed from bi-pap due to recall.The prescription i was given is not covered by insurance or in my case an (b)(6).The meds are (b)(6).This fungus has a 80% mortality rate.I need for someone to pay for this medicine because without it, i will die.I was released from the hospital on (b)(6) 2021.

• Brand Name: PHILLIPS RESPERONICS BI-PAP
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): PHILLIPS RESPIRONICS INC.
• MDR Report Key: 12195930
• MDR Text Key: 262641842
• Report Number: MW5102626
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/16/2021

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 59 YR
• Patient Weight: 95