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

Device Problems Device Emits Odor (1425); Product Quality Problem (1506)

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

Event Date 05/22/2022

Event Type  Injury  

Event Description

I nearly brand new phillips dream mapper was recalled.The philips company sent me a nasty old unit with lots of hours on it.The machine looks ok, but it stinks of nicotine.I have copd and asthma and can't be using a machine like this horrible old unit.

• Brand Name: PHILIPS DREAMMAPPEER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 16590211
• MDR Text Key: 311828465
• Report Number: MW5115896
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: VALSARTAN
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White