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

Device Problem Break (1069)

Patient Problems Asthma (1726); Headache (1880); Caustic/Chemical Burns (2549); Cough (4457); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Began using dream station cpap(continuous positive airway pressure) in 2019; chemical burns on face in 2021 from cpap exploding, irritated eyes and respiratory tract, worsened copd(chronic obstructive pulmonary disease) and asthma, headaches, and cough.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17217867
• MDR Text Key: 318113391
• Report Number: MW5118872
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: TACROLIMUS
• Patient Outcome(s): Hospitalization; Disability; Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Female