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

Model Number DSX500

Device Problems Contamination (1120); Nonstandard Device (1420)

Patient Problems Sore Throat (2396); Cough (4457)

Event Date 03/19/2023

Event Type  Injury  

Event Description

My philips dreamstation c-pap was among those that were recalled.I registered my device for remediation in (b)(6) 2021.After a long wait, i finally received my replacement unit this month.The remediated device i received is dirty.It is visibly soiled externally and had a hair under the filter.I cleaned all accessible portions of the unit and started using it 2 nights ago.After the first night of use i had a mild cough.Today, i have a deep productive cough and a sore throat.Per the philips website, "when we refurbish the affected devices with a new blower and air pathway, we also clean and disinfect them".I'm concerned that the internal components of the remediated device i received may not have been cleaned/sanitized any better than the outside of the unit was.Reference report mw5115916.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS INC.
• MDR Report Key: 16597557
• MDR Text Key: 311936054
• Report Number: MW5115917
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BUPROPION SR; MULTIVITAMIN ; VIIBRYD
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White