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

Device Problem Compatibility Problem (2960)

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

Event Description

I was sent a replacement machine but they sent a bi-pap and i needed a cpap.Getting no where with this issue "wit" philips.I need a cpap replacement asap.Doctor says no to the bi-pap.Please help me with this.

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 14470656
• MDR Text Key: 292503755
• Report Number: MW5109818
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White