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

Catalog Number REF. # DSX500H11C

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

I have a philips dreamstation cpap machine serial #: (b)(4).On a couple of occasions over the past couple of months, i have found a black graphite-like substance clogging the temporary and permanent air filters.The substance permanently stains the filters and cannot be washed out.The filters must be destroyed.Disturbed about the substance, i notified (b)(6) who told me not to worry about it.Last week i received a letter from philips stating that the sound abatement foam they used was degrading and could be inhaled.They instructed me to complete a form and noted the company was "deploying a permanent corrective action." phillips did not state what the corrective action would be nor did they provide a time-frame for this corrective action.How do i know if i inhaled any of the chemicals? i am appraising the fda of this situation.I know nothing about the remaining test questions on the form.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION AUTO CPAP HUMCELL DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12313299
• MDR Text Key: 266604107
• Report Number: MW5103195
• 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: 08/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: REF. # DSX500H11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 118