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

Model Number DSX500H11C

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Cyst(s) (1800); Itching Sensation (1943); Red Eye(s) (2038); Sore Throat (2396); Balance Problems (4401); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/17/2021

Event Type  Injury  

Event Description

I have been using two of the recalled philips cpap machines since 2013.I have had numerous health issues that seem to be related to these cpap machines.I have a constant sore throat.My eyes are red continuously.They also itch.My nose burns.I have a cyst on my thyroid.I have unexplained muscle loss.My absolute lymphocyte counts are low continuously.I have been tested for allergies and have none.I have a potential tumor in my ear canal.I have balance issues.I have a runny nose when using the device and most of the day afterward.I have numerous nasal polyps documented by an mri.I have medical records to document most of these claims.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPERONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12506657
• MDR Text Key: 272706340
• Report Number: MW5104088
• 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: 09/17/2021

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: No Information
• Device Model Number: DSX500H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 88