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

Device Problem Degraded (1153)

Patient Problems Stacking Breaths (1593); Asthma (1726); Chest Pain (1776); Numbness (2415); Sleep Dysfunction (2517); Cough (4457)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

The 510k number and the exact recall number could not be provided since no device information was provided.Possible recall numbers include z-1972, z-1973, and z-1974.H3 other text : device not yet 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 voluntary medwatch (mw5151739).The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged with inhaling, chest pain, voice problems, coughing, labored breathing, asthma, hemangioma (inter-muscular growth on the back of her neck), thymoma, sleep disturbances.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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 Key: 18893213
• MDR Text Key: 337529329
• Report Number: 2518422-2024-13650
• 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: 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: 03/13/2024
• 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 Received: 03/07/2024
• 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