MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS 30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130T11C

Device Problem Degraded (1153)

Patient Problem Dyspnea (1816)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information that patient alleging difficulty breathing/short of breath.The patient reported that the device has had mold underneath the lid for over a year which patient has been using vinegar and water to clean it out.Medical intervention was not specified.The patient required prescription medications, admitted to hospital, spell out what the intervention was.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 BIPAP AVAPS 30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19039107
• MDR Text Key: 339325104
• Report Number: 2518422-2024-17247
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045668
• UDI-Public: 00606959045668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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
• Device Model Number: DSX1130T11C
• Device Catalogue Number: DSX1130T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1