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

Model Number DSXS00T11C

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Pneumonia (2011); Respiratory Tract Infection (2420); Cancer (3262)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Began using the recalled philips cpap (b)(6) 2021.Diagnosed with cervical cancer in (b)(6) 2021.Has had respiratory issues, headaches.Has been hospitalized for non-covid pneumonia.Doctors stated there was substances in lungs that looked like gel or glass.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 17228384
• MDR Text Key: 318289635
• Report Number: MW5118959
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSXS00T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HYDROXYCHLOROQUINE.; NEBULIZER. ; PREGABALIN.; PROERANOLOL.; TANTOPRAZOLE.; TOEIRAMATE.; VITAMIN D3.
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 62 YR
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White