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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Nausea (1970); Eye Pain (4467)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of black particles in tubing/chamber and also alleged headache, nausea and eyes feel puffy or irritated.There is no allegation of serious or permanent harm or injury.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 received information alleging black particles in tubing/chamber and also alleged headache, nausea and eyes feel puffy or irritated and burning or smoke or electrical odor related to a cpap device's sound abatement foam.There was no report of serious or permanent patient harm or injury.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final 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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged visualization of particles.There was no report of serious or permanent harm or injury.Additional information was received and added to the report.The device was returned to the manufacturer's service center on 09/20/2023 for further evaluation.The device was evaluated on 10/20/2023.As per the investigation of the device evidence of sound abatement foam degradation/breakdown was not observed in the base unit.As per exterior investigation, observed unknown dust/dirt contamination present on all surfaces of the base unit.The device did not return with an accessory port flip door, sd card, or filter.There is an unknown dust contaminate present at the air inlet where the filter would be and at the iso port entrance.There is unknown dust/dirt contamination behind the ui knob.As per interior investigation, unknown debris in the tracks of the ui panel.There is an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, blower impeller, and rear panel o-ring.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The device's downloaded event log was reviewed by the manufacturer and found 2 errors.The manufacturer concludes unable to address the symptoms described and confirm the presence of contamination in the airpath.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: 14391066
• MDR Text Key: 291634099
• Report Number: 2518422-2022-18635
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• 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