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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERMANENT AIR FILTERS DISINFECTANT, MEDICAL DEVICES

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PERMANENT AIR FILTERS DISINFECTANT, MEDICAL DEVICES Back to Search Results
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).
 
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Brand NamePERMANENT AIR FILTERS
Type of DeviceDISINFECTANT, MEDICAL DEVICES
MDR Report Key12313299
MDR Text Key266604107
Report NumberMW5103195
Device Sequence Number2
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received08/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberREF. # DSX500H11C
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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