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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Ulcer (2274); Sore Throat (2396); Respiratory Tract Infection (2420); Cough (4457); Epistaxis (4458)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

A user contacted the manufacturer regarding the sound abatement foam correction/removal for their cpap device.The user reported burning/smoke/electrical odor; noise; nose bleeds, congestion, coughing phlegm; mouth sores/bleeding; nasal/throat irritation.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

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 a cpap device's sound abatement foam.The patient alleged burning/smoke/electrical odor; noise; nose bleeds, congestion, coughing phlegm; mouth sores/bleeding; nasal/throat irritation.There was no allegation of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation, evidence of sound abatement foam degradation/breakdown was not observed in the base unit.Observes dust/dirt and fibrous contamination, inconsistent with sound abatement foam degradation, throughout the device enclosure and airpath, suggesting that it originated from an external source.Observes brown/yellow contamination throughout the device enclosure, suggesting a source external to the device.Observes evidence of water ingress in the blower box and blower, suggesting the use of non-distilled water in the humidifier water chamber.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed.The device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes unable to address the symptoms described.Pil can confirm the presence of contamination in the airpath.Can confirm the device powers on and provides airflow.Can confirm evidence of water ingress in the blower box.

• 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: 13905224
• MDR Text Key: 297799783
• Report Number: 2518422-2022-11885
• 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
• Report Date: 01/17/2024

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: 02/23/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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