MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS DREAMSTATION BIPAP AUTOSV MACHINE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900H11C

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Fever (1858); Headache (1880); Sore Throat (2396)

Event Date 01/17/2022

Event Type  Injury  

Event Description

After using my bipap machine, i noticed i was waking up with a pounding heart.I've also had related headache, sore throat and nose, and fever.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION BIPAP AUTOSV MACHINE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13334205
• MDR Text Key: 284375771
• Report Number: MW5106901
• Device Sequence Number: 1
• Product Code: MNS
• 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: 01/19/2022

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: DSX900H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL ; LISINOPRIL
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White