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

Model Number DSX500T11W

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Myocardial Infarction (1969)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a heart attack.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to heart attack, device will not turn on/device not functioning and smells like burning or mildew smell from the device.The reported event of heart attack and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of the device was completed by the manufacturer and observed an unknown contaminant on the sd card flip door.A white unknown contaminant inside the iso port of the rear panel.An unknown dust contaminant and hair-like particle were observed on the top enclosure.An unknown dust contaminant was observed on the front panel, rear panel, bottom enclosure, blower, blower seal, and blower box.Evidence of liquid ingress with a dust contaminant consistent with mineral deposits was observed to the blower and blower box.The device's event logs were downloaded and reviewed by manufactuer.The manufacturer found 1 error code.The manufacturer powered up the device and confirmed airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation/breakdown.Sections b1, b2 has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, medical device problem code, type of investigation, investigation findings and investigation conclusions 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: 13251451
• MDR Text Key: 283762453
• Report Number: 2518422-2022-00793
• 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
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11W
• Device Catalogue Number: DSX500T11W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• 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