MAUDE Adverse Event Report: RESPIRONICS, INC DREAMSTATION AUTO CPAP W/HUM/CELL, DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Blurred Vision (2137); Dizziness (2194); Sore Throat (2396); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient 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 previously reported an allegation of an issue related to sound abatement foam.This action was reported to fda per 21 cfr part 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 black particles in their nose, and experienced headaches, dizziness, sore throat, blurry vision, partial blindness, unable to walk and/or drive sometimes, visual disturbance, and had their walking.There was no medical intervention required by the patient.The reported events were reviewed by the manufacture's clinical expert.This events are not assable due to insufficient information.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the external part of the device and found discolouration of blower assembly.The manufacturer inspected the device internally and found multiple contaminants, including insect remains observed in base unit enclosure.Dark organic contamination was observed in the humidfier on the heated tubing wires beneath the wire cover.Multiple unidentified contaminants including fibre / hair and partial insects remains found in the interior base unit.Dust contamination was observed in the blower and on blower impeller.The blower discolouration suggests possible liquid ingress.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found nine error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation, but a small amount of liquid ingress and dust contamination were observed and are consistent with being from an external source.Section h6 has been updated in this report.

• Brand Name: DREAMSTATION AUTO CPAP W/HUM/CELL, DOM
• 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: 12307045
• MDR Text Key: 266001269
• Report Number: 2518422-2021-03016
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/15/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/15/2021; 08/26/2022
• Supplement Dates FDA Received: 08/30/2021; 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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 Sex: Female