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

Model Number GO

Device Problem Nonstandard Device (1420)

Patient Problems Decreased Sensitivity (2683); Taste Disorder (4422)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Decreased sense of smell and taste.This had improved, though not completely, since stopping use of my philips dreamstation go cpap device following the recall.

• Brand Name: DREAMSTATION GO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16701403
• MDR Text Key: 312985713
• Report Number: MW5116437
• 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: 04/04/2023

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: GO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Patient Sequence Number: 1
• Treatment: CPAP, LISINOPRIL, REPATHA, STEROID CREAM.
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White