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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); Headache (1880); Nausea (1970); Vertigo (2134); Vomiting (2144)

Event Date 07/24/2018

Event Type  Injury  

Event Description

While i was at work i was suddenly overcome with severe dizziness and nausea (vomiting).Since then i continue to get bad headaches and severe vertigo where i cant walk without losing my balance and falling.Spent multiple visits to the house ear clinic to try to determine why i was having dizzy spells all the time.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12916584
• MDR Text Key: 281669909
• Report Number: MW5105706
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: D3; DICYCLOMINE; ELLIQUIS; EXCEDRIN MIGRAINE; LISINOPRIL; LORAZEPAM ; MONTELUKAST; PRILOSEC ; ROSUVASTATIN ; ZINC; ZYRTEC
• Patient Outcome(s): Disability
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White