MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Hemoptysis (1887)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged blood clots.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 previously reported an allegation of an issue related to a bipap device's sound abatement foam.The manufacturer received information alleged blood clots.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's service center for further evaluation.The evidence of sound abatement foam degradation/breakdown was not observed in the base unit but the device was evaluated and slight dust/dirt contamination inconsistent with degraded sound abatement foam was abserved throughout device enclosure and airpath, suggesting a source external to the device.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.The manufacturer found 4 errors found (err_sensor_unreliable (1127179 v04)).The manufacturer concludes that they confirm the customer's allegation and there is dust / dirt contamination and the presence of contamination in the airpath, source of contaminations were external to the device.

• Brand Name: DREAMSTATION BIPAP ST30
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13518259
• MDR Text Key: 291283461
• Report Number: 2518422-2022-03412
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2019
• 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