MAUDE Adverse Event Report: PHILIPS CPAP DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Pulmonary Edema (2020); Respiratory Tract Infection (2420); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)

Event Date 10/12/2023

Event Type  Injury  

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 been returned to the manufacturer.

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 respiratory tract irritation, asthma, kidney disease, lung disease, recurrent fluid in lungs and heart.The patient was placed on kidney dialysis back in 2019.There was no medical intervention required by the patient.Due to potential litigation surrounding this case, no follow up can be performed at this time.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: PHILIPS CPAP DEVICE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• MDR Report Key: 18716061
• MDR Text Key: 335499798
• Report Number: 2518422-2024-07676
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other