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

Model Number DSX500H11

Device Problem Degraded (1153)

Patient Problems Pneumonia (2011); Respiratory Tract Infection (2420); Eye Burn (2523); Embolism/Embolus (4438)

Event Date 11/10/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged having blood clots in both lungs, pneumonia, continuous sinitis and every morning after use, eyes burn badly until washes them out.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

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 cpap device's sound abatement foam.The manufacturer received information that the patient alleged having blood clots in both lungs, pneumonia, continuous sinitis and every morning after use, eyes burn badly until washes them out.The device was returned to the manufacturer's product investigation laboratory for investigation.As per the investigation of the device confirmed no presence of degraded sound abatement foam.Powered up the device using a known good power supply and power cord, confirmed airflow, a known good heated tube heats, and the heater plate heats.The device's downloaded event log was reviewed by the manufacturer and found two erorrs.The manufacturer concludes confirmed no presence of degraded sound abatement foam and unable to directly address the symptoms or complaints.In this report, section d9, g3, h3, h6 has been updated.

• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15139087
• MDR Text Key: 296975342
• Report Number: 2518422-2022-67968
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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