MAUDE Adverse Event Report: RESPIRONICS DREAM STATION BIPAPSV. DS; VENTILATOR, CONTINUOUS, NON LIFE-SUPPORTING

Lot Number DSX900S11

Device Problems Pressure Problem (3012); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

I¿ve had two respironics philips dream station s/n: (b)(4).Auto sv bipap machin, ref # dsx900s11 with air blower malfunction that were new.First one made loud clicking sounds from the motor or blower.It was replaced by a second unit which did the same thing with the motor after two weeks after i received the unit and a loud whistle is being made with the second replacement unit.I was unable to sleep with the sound and the pressures seemed to be much lower in pressure and not treating my sleep apnea.Fda safety report id # (b)(4).

• Brand Name: DREAM STATION BIPAPSV. DS
• Type of Device: VENTILATOR, CONTINUOUS, NON LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 9458744
• MDR Text Key: 170865976
• Report Number: MW5091609
• Device Sequence Number: 1
• Product Code: MNS
• 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: 12/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: DSX900S11
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR