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

Model Number J309794839ECB

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Vertigo (2134); Dizziness (2194)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Vestibular neuritis; started with severe headaches, nasal congestion, sinus pain, vertigo, dizziness, sinus infection.Requiring multiple dr appointments.Antibiotics, steroids x2 missed work.Unable to drive active recall on cpap machine with gas exposure listing above symptoms.Started using this device 1 month prior to the above issues.Have been fighting these symptoms for 25 days and worse in morning after cpap use.Fda safety report id # (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12106794
• MDR Text Key: 260016603
• Report Number: MW5102230
• Device Sequence Number: 1
• Product Code: BZD
• 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: 06/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J309794839ECB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 82