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

Model Number DSX400H11

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420)

Patient Problem Unspecified Infection (1930)

Event Date 05/03/2021

Event Type  Injury  

Event Description

Patient was using a philips respironics dreamstation cpap.They had a black substance leaking out of humidifier chamber and tubing.Patient has had an on going sinus infection and problems for a few months now.We replaced the tubing and humidifier chamber.About a month later all the dreamstation cpap's have been recalled.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS, INC. ; atlanta GA 30384 5740
• MDR Report Key: 12066881
• MDR Text Key: 258699788
• Report Number: MW5102148
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400H11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 86