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

Model Number DSX500H11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Epistaxis (4458)

Event Date 11/08/2021

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.A correction to b5 was made and should be: 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 a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a heart attack, nose bleeds and difficulty breathing/short of breath.There is no report of the medical intervention that the patient has received at this time.There is no serious harm or injury to the patient.The device was returned to the product investigation laboratory for further evaluation.The device was evaluated.The device powered on and airflow was confirmed.The manufacturer observed minor dust/dirt contamination on ui panel, control dial, blower, and bottom enclosure.Unknown contaminate on ui panel, rear panel, and dc jack color insert.There was corrosion on the p4 power connector.Black particles on blower box upper cap, blower box, and blower.Liquid ingress with mineral deposits were observed on the blower and p4 power connector.The manufacturer was able to conifrm the presence of degraded sound abatement foam residue.The device's downloaded logs were reviewed by the manufacturer.There were five errors found.The manufacturer concludes that they could not confirm the customer's allegation and there was visible foam degradation.Section(s) 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 has been corrected and updated.Section h6 health effect clinical code has been updated (missed to capture all the relevant codes).Section h6 - medical device problem code, component code , type of investigation, investigation findings and investigation conclusions have been updated in this report.

• 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: 12932883
• MDR Text Key: 281733487
• Report Number: 2518422-2021-07684
• 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: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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