MAUDE Adverse Event Report: RESPIRONICS, INC. PHILIPS CPAP DEVCIE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Inflammation (1932); Nausea (1970); Vomiting (2144); Dizziness (2194); Respiratory Tract Infection (2420); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)

Event Date 10/09/2023

Event Type  Death  

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 philips cpap device's sound abatement foam.The patient allegedly passed away.In addition, there were allegation of kidney disease/toxicity, asthma, reduced cardiopulmonary reserve, lung disease, and cancer, eye irritation, nose irritation, respiratory tract irritation, dizziness and/or headaches, nausea/vomiting, and inflammatory response.No further clinical details or medical intervention were reported.Due to potential litigation surrounding this case, no follow up can be performed at this time.If any additional information is received, a follow up report will be filed.

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 not returned to the manufacturer.

• Brand Name: PHILIPS CPAP DEVCIE
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19184653
• MDR Text Key: 341075125
• Report Number: 2518422-2024-22442
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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 Received: 04/25/2024
• 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
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death