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

Catalog Number UDSX500S11F

Device Problems Contamination (1120); Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  Injury  

Event Description

Filed for the philips respironics dreamstation 1 replacement in (b)(6) 2022 due to the recall.On (b)(6) 2022 received my replacement device.The device sent was re-certified and claimed to be sanitized and cleaned by philips, according to the letter i was provided with the re certified device.Upon opening the device and before any use i inspected the device and noticed small hairs, crumbs, and what appears to be dried up mucus throughout the device.The device does not appear clean or sanitized and poses serious health conditions if i was to use it.Will provide several images showing the condition of the device.Currently using philips dream station auto cpap that was purchased 1 plus years ago.Have not used the re certified one.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15515859
• MDR Text Key: 301036624
• Report Number: MW5112351
• 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: 09/24/2022

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 Catalogue Number: UDSX500S11F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 150 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White