MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV; VENTILATORY SUPPORT SYSTEM

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Unspecified Heart Problem (4454); Swelling/ Edema (4577)

Event Date 04/04/2022

Event Type  Injury  

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 alleging an issue related to a bipap device's sound abatement foam.The patient has alleged to stressed heart, worse chf, swollen legs, bad heart, chronic afib, mitryol valve repair.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATORY SUPPORT SYSTEM
• 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: 16061430
• MDR Text Key: 306267138
• Report Number: 2518422-2022-103382
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other