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

Model Number DREAMSTATION

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/28/2020

Event Type  Injury  

Event Description

Rubber seals began falling out of my dreamstation bipap.I have added a bacterial filter based on my dme provider recommendation and stopped using my humidifier.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP HUMHT CELL
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12306971
• MDR Text Key: 266206285
• Report Number: MW5103141
• 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: Patient
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION
• Device Lot Number: 2020-07-31
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 99