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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Sore Throat (2396); Respiratory Tract Infection (2420); Taste Disorder (4422)

Event Date 09/23/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged having nasal/throat irritation or soreness and lost sense of taste.There was no report of serious 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 reported an allegation of burning smell related to a cpap device's sound abatement foam.The patient alleged having nasal/throat irritation or soreness and lost sense of taste.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.As per the investigation of the device evidence of sound abatement foam degradation/breakdown was not observed in the base unit and device provided airflow during therapy.As per secondary findings of the base unit observed evidence of water ingress on the blower and blower box, dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device, corrosion was observed.This is likely the cause of any burning odor.The device's downloaded event log was reviewed by the manufacturer and found no erorrs.The manufacturer concludes unable to address the symptoms described and confirm the presence of contamination in the airpath.In this report, section d9, g3, h3, h6 has been updated.

• 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: 15199190
• MDR Text Key: 297871248
• Report Number: 2518422-2022-70144
• 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: 07/19/2023

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: 09/23/2021
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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