MAUDE Adverse Event Report: RESPIRONICS, INC. DREAM STATION AUTO CPAP HUM HT CELL DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500T11C

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

Small black particles were noted in the water chamber.Fda safety report id # (b)(4).

• Brand Name: DREAM STATION AUTO CPAP HUM HT CELL DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 15485177
• MDR Text Key: 300704680
• Report Number: MW5112254
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: (01)00606959022652
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSXHCP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL 200 MG PRN ; LOSARTAN 100 MG DAILY; TYLENOL XTRA STRENGTH PRN
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White