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

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Tooth Fracture (2428); Epistaxis (4458)

Event Date 06/25/2021

Event Type  Injury  

Event Description

Woke up one morning with evidence of bloody nose having occurred during the night.Had a broken tooth a few nights later.Bloody noses began to become frequent along with increased post nasal drip and chronic sinus infection.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: 12583237
• MDR Text Key: 275189033
• Report Number: MW5104406
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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): Disability
• Patient Age: 37 YR
• Patient Weight: 179