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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Dizziness (2194); Respiratory Tract Infection (2420); Solid Tumour (4552)

Event Date 11/01/2021

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 and mechanical ventilator devices.The manufacturer received information alleging dizzy and have headaches, difficulty breathing and shortness of breath and throat irritation, surgery due to lump in the lungs while using this device.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

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 received information alleging dizzy and have headache, difficulty breathing and shortness of breath and throat irritation, surgery due to lump in the lungs while using this device related to a cpap device's sound abatement foam.This event is assessed as not related to the device in this case.The patient did not receive any medical intervention.The device was returned to the manufacturer's service center for further evaluation.  the manufacturer evaluated the device externally /internally and observed unknown white deposits in filter inlet and air inlet and unknown brown debris consistent with keratin found in the filter inlet.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There was 1 error found.The manufacturer concludes that they could not confirm the customer's allegation and they could not confirm the presence of degraded sound abatement foam and there is no visible damage or functionality failures of the device still which suggests the source of contamination was external to the device.

• Brand Name: DREAMSTATION AUTO CPAP
• 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 shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15430940
• MDR Text Key: 300027555
• Report Number: 2518422-2022-81035
• Device Sequence Number: 1
• Product Code: BZD
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 09/15/2022
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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
• Patient Outcome(s): Other