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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Rash (2033); Burning Sensation (2146); Sore Throat (2396); Respiratory Tract Infection (2420); Eye Burn (2523)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged nasal/throat irritation or soreness, nose and eyes burn, rash on the side of nose.There was no report of seriuos or permanent 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 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 nasal/throat irritation or soreness, nose and eyes burn, rash on the side of nose related to a cpap device's sound abatement foam.There was no report of patient harm or injury.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.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Section h6 updated in this report.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.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 a cpap device's sound abatement foam.The manufacturer received information alleged nasal/throat irritation or soreness, nose and eyes burn, rash on the side of nose.There was no report of serious or permanent harm or injury.Additional information was received and added to the report.The device was returned to the manufacturer's product investigation laboratory for investigation on 05/12/2023 for further evaluation.The device was evaluated on 06/08/2023.There was no mention of visual findings to the external part of the device.Using a known good power supply and cord pil applied power.Review of the error log shows 0 errors.0 blower hours and 0 therapy hours were logged, suggesting the device data was reset prior to pil receipt.2710.8 machine hours were logged.Internal investigation of the base unit observed evidence of dust contamination on the blower and in the blower.Using the fit tool pil observed foam adhering to the tool confirming the presence of degraded sound abatement foam.Pil observed evidence of water ingress on the blower.Pil is unable to address the symptoms described.Pil can confirm the presence of dust in the device and airpath.Pil can also confirm the presence of degraded sound abatement foam, however no visible amounts of foam were observed to be missing.Section h6 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: 15195966
• MDR Text Key: 303242530
• Report Number: 2518422-2022-70588
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 02/17/2023; 06/08/2023
• Supplement Dates FDA Received: 03/13/2023; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• 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