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

Patient Problems Asthma (1726); Dyspnea (1816); Dizziness (2194); Numbness (2415); Sleep Dysfunction (2517); Cough (4457); Unspecified Respiratory Problem (4464); Solid Tumour (4552)

Event Type  Injury  

Event Description

Reporter stated that she has been using cpap device for about 10 years.Shortness of breath was the only thing she was experiencing before using the device.However, while she was using the device, she was having the following adverse events: pain with inhaling, chest pain, voice problems, coughing, labored breathing when she is going up and down the stairs, numbness on her tongue, asthma, hemangioma (inter-muscular growth on the back of her neck), thymoma, sleep disturbances.She went on saying, when she is having difficulty, she is trying to stand up to alleviate her symptoms and she feels like she is about to pass out.She said she did not know the cause of her symptoms were the cpap machine until it is much later.She returned her device per the manufacturer¿s instructions since it has been under recall.She said, she has received a replacement device, but she has not used it since she has lost trust based on her experience with the previous device.She is now taking mandatory steroid inhaler to help her breath better.She said she has not gotten better fully but she is getting some relieves using that treatment.

• Brand Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 18720882
• MDR Text Key: 335733256
• Report Number: MW5151739
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/15/2024

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
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic