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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Itching Sensation (1943); Pain (1994); Rash (2033); Discomfort (2330); Sleep Dysfunction (2517)

Event Date 07/12/2022

Event Type  Injury  

Event Description

Noticed rash on right cheek, neck and ears due to saliva after receiving new cpap equipment after recall.Rash started severely itching and spread so i stopped using new cpap.Itch and discomfort became more severe as it spread into ear canals and into throat and mouth.Consulted various doctors but none could identify type of rash.Nightly earache and headache becoming more common, disturbing sleep.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15807022
• MDR Text Key: 303905527
• Report Number: MW5113320
• 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: 11/14/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Patient Sequence Number: 1
• Treatment: AMLODIPINE BESYLAT 2.5; IROSINT 88; LIOTHYRONNE SOD
• Patient Outcome(s): Disability
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White