MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX1030T11C

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Unspecified Respiratory Problem (4464); Unspecified Hepatic or Biliary Problem (4493)

Event Date 10/13/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused chest pain, spots on liver and lungs.The patient did not report receiving any medical intervention.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

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.Patient alleged chest pain, spots on liver and lungs.No medical intervention was reported.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.One error was found.The manufacturer concludes that the customers allegation could not be confirmed and there was no visible foam degradation.Section d8, d9, h2, h3 and h6 has been updated.

• Brand Name: DREAMSTATION BIPAP ST30
• 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 15206 ; 2673970028
• MDR Report Key: 12738245
• MDR Text Key: 279596055
• Report Number: 2518422-2021-06132
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045606
• UDI-Public: 00606959045606
• 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,Followup
• Report Date: 08/29/2023

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: DSX1030T11C
• Device Catalogue Number: DSX1030T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other