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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Apnea (1720); Asthma (1726); Chest Pain (1776); Cyst(s) (1800); Dyspnea (1816); Headache (1880); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Sore Throat (2396); Hematuria (2558); Unspecified Respiratory Problem (4464); Kidney Infection (4502)

Event Date 12/15/2021

Event Type  Injury  

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 cysts in their eyes and nostrils, hematuria, and chronic obstructive pulmonary disease.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 cpap device's sound abatement foam.The patient alleged to experience black stuff in the filters, severe sore throat, headaches, dizzy spells, acute lightheaded, severe eye irritation, cyst on eyes and inside nostrils, severe apnea heart palpitations, hematuria, chest pain, kidney infections, copd, asthma, associated with difficulty breathing/short of breath from the device.There was no medical intervention required by the patient.The reported event 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 manufacture concludes no further action is necessary.There was no medical intervention required by the patient.  the device has not yet returned to the manufacturer for evaluation.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 at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.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, type of investigation findings and investigation conclusions has been updated.

Manufacturer Narrative

The manufacturer previously submitted mdr 2518422-2022-00534-1 with incorrect sections b1, b2, h1, h6.Corrections to previous mdr are made in this report as follows.Section b1 was corrected to adverse event and product problem.Section b2 was corrected to other serious or important medical events.Section h1 was changed from malfunction to serious injury.Section h6- health impact code was updated.

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 cpap device's sound abatement foam and became degraded and caused the patient to have severe sore throat, headache, dizziness, acute lightheaded, eye irritation, cysts on eyes and in nostril, severe apnea, copd, asthma, black particles in filter, heart palpitations, kidney infection, hematuria, chest pain and difficulty breathing/short of breath.Also, device has strange odor.The medical intervention that the patient received in response to the event is currently unknown.The device was returned to the manufacturer's product investigation laboratory for investigation.The evidence of sound abatement foam degradation/breakdown was not observed in the base unit but the device was evaluated and a white unknown dust contaminant inside the blower box at the air inlet.An unknown contaminant was observed inside the iso port of the rear panel, the top enclosure, front panel, rear panel, bottom enclosure, blower box outlet, blower, blower seal, and blower box.The manufacture observed the evidence of liquid ingress on the blower and blower box.Also, a keratin-like substance was observed on the blower box outlet.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and there is dust / dirt contamination and the presence of contamination in the airpath, source of contaminations were external to the device.Section h6 was corrected and 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: 13223314
• MDR Text Key: 283587732
• Report Number: 2518422-2022-00534
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2018
• 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