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

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Nausea (1970); Pain (1994); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device has not been returned to the manufacturer.

Event Description

The manufacturer received a voluntary medwatch (mw5102806) in reference to the field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging that the patient is experiencing significant upper respiratory issues (congestion, stuffy/runny nose, and copious drainage), fatigue, nausea from swallowing post-nasal drip, coughing, and pain in the ribs and diaphragm from coughing.There is no allegation of serious or permanent harm or injury.The patient has seen a pulmonologist and an ent and both physicians have been unable to identify the source of the patient's respiratory issues definitely.The patient was administered a new pulmonary function test and a ct of their sinuses; nothing new was identified.The patient also took a covid test.The patient questions if the toxic gases emitted by the machine are the source of their symptoms.The device has not yet been returned to the manufacturer for evaluation, and there is no contact information for the initial reporter to gain additional information on the device.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)
• 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: 17712817
• MDR Text Key: 322988567
• Report Number: 2518422-2023-22086
• 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: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2021
• 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: RES 88058
• Patient Sequence Number: 1