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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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RESPIRONICS, INC. PHILIPS CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Degraded (1153); Chemical Problem (2893)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2023
Event Type  malfunction  
Event Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received allegation of exposure to dangerous toxins.There was no report of patient harm or injury.The manufacturer was made aware of this complaint through a representative of the customer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
H3 other text : the device not yet returned to the manufacture.
 
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Brand Name
PHILIPS CPAP DEVICE
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
6501 living place
pittsburgh, PA 15208
4125423300
MDR Report Key18099051
MDR Text Key327707426
Report Number2518422-2023-29582
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1974-2021
Patient Sequence Number1
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