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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 Problem Degraded (1153)
Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Nausea (1970); Dizziness (2194); Sore Throat (2396); Embolism/Embolus (4438)
Event Date 10/23/2023
Event Type  Injury  
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 information alleging an issue related to a cpap device's sound abatement foam.The patient alleged blood clot, chest pains, throat irritation, nausea, lightheaded, dizziness, headaches and difficulty breathing.There was no report of serious or permanent patient harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
 
Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device has not returned to the manufacturer for evaluation.
 
Manufacturer Narrative
The manufacturer was previously 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 information alleging an issue related to a cpap device's sound abatement foam.The patient had alleged blood clot, chest pains, throat irritation, nausea, lightheaded, dizziness, headaches and difficulty breathing.There was no report of serious or permanent patient harm or injury.Upon further assessment based on the additional information received on pms decision, this report is now being filed as an adverse event instead of a product problem.Section adverse event, product problem, adverse event outcomes attributed to ae and type of reported complaint has been changed, updated in this report.
 
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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 Key18096646
MDR Text Key327677261
Report Number2518422-2023-29520
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,Followup
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? No
Initial Date Manufacturer Received 10/23/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received11/10/2023
Supplement Dates FDA Received11/14/2023
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
Patient Outcome(s) Other;
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