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

Model Number DSX520H11C

Patient Problem Aspiration/Inhalation (1725)

Event Date 02/20/2024

Event Type  Injury  

Event Description

I was using philips dreamstation-2 cpap machine as recommended by my doctor.Some white powder like substance spreading / coming out from machine.I stopped using the cpap machine to prevent further negative effect on my health from using the machine.I got this cpap machine from philips after previous machine was recalled.Reference report: #mw5153697.

• Brand Name: CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 19087244
• MDR Text Key: 340125688
• Report Number: MW5153696
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959062733
• UDI-Public: (01)00606959062733
• 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: 04/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2024
• Patient Sequence Number: 1
• Treatment: AZITHROMYCIN-250MG.; CALCIUM.; METFORMIN-500MG.; MONTELUKAST-10MG.; ROSUVASTATIN 20MG.; TRELEGY.; VITAMIN-D.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian