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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Asthma (1726); Cyst(s) (1800); Headache (1880); Pneumonia (2011); Red Eye(s) (2038); Sinus Perforation (2277); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2021

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 kidney stones, a cyst on their kidney, and lung nodules.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 issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient did not report to receive medical intervention.The patient also alleged headaches, asthma, sinus infections, kidney stones-large cyst on left kidney, constantly getting pnuemonia, red eyes, nodules on lungs, sleep apnea got a lot worse and stated leaking from device.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the external investigation showed that unknown brown residue in filter inlet consistent with keratin on device, unknown white debris consistent with dust found on top of blower and on the inside of the bottom of blower box of device, unknown debris in tube inlet of humidifier, unknown white residue on heat plate of humidifier, unknown debris on bottom of inside the humidifier, scratches on inside surface of reservoir.The manufacturer was not able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no visible damage or functionality failures of the device, which still suggests that the source of contamination was external to the device.Section h6 were 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: 12664945
• MDR Text Key: 277379030
• Report Number: 2518422-2021-05546
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 06/23/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2018
• 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