MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Decrease in Pressure (1490)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to a dreamstation 2 cpap device.The manufacturer received voluntary medwatch (mw5151855).The machine was a replacement machine.The manufacturer received information about the device malfunctioning.It started having pressure problems after approximately one year.The machine provided intermittent pressure during the night and would self-activate to lower the pressure, leading to a too low pressure, thus providing insufficient air for proper treatment.Reporter called philips for assistance and troubleshooting and was told that he would need to have the pressure tested by a durable medical equipment (dme) representative by philips.There are no representatives in his area, so he took it to his physician who tested the machine.The results indicated malfunction, but philips will not replace his machine because it was not pressure-tested by a philips dme.The machine is still under warranty but philips refuses to replace the defective unit.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: DREAMSTATION 2 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18938589
• MDR Text Key: 338081661
• Report Number: 2518422-2024-14464
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1