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

Model Number IP22

Device Problems Contamination (1120); Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Started getting repetitive sinus and upper respiratory issues over several months requiring doctors visits.I noticed black residue in the water reservoir not knowing what it was until i saw the recall notice from philips on the cpap i am using.I continue to use without heat or water per my physician.It is a philips respironics dreamstation.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12844178
• MDR Text Key: 281099948
• Report Number: MW5105469
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IP22
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: KRILL OIL; VITAFUSION C; VITAFUSION MENS MULTI
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White