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

Model Number DSX400T11C

Device Problems Degraded (1153); Contamination /Decontamination Problem (2895)

Patient Problems Dyspnea (1816); Unspecified Respiratory Problem (4464)

Event Date 07/23/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged congested and hard of breathing, difficulty breathing or short of breath.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 previously reported an issue related to a cpap device's sound abatement foam.The patient alleged congested and hard of breathing, difficulty breathing or short of breath.There was no report of patient harm or injury.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 no evidence of degraded sound abatement foam.The manufacturer visually inspected the device and found presence of dust/dirt contamination arround the air inlet and iso port.Grey film contaminant on the top enclosure, front panel, rear panel and bottom enclosure.Dark contaminant found at blower box.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found 1 error code.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was evidence of contamination in the airpath and no evidence of sound abatement foam degradation.Section h6 were updated in this report.

• Brand Name: DREAMSTATION CPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburg, PA 15206 ; 2673970028
• MDR Report Key: 15188551
• MDR Text Key: 303185535
• Report Number: 2518422-2022-69841
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400T11C
• Device Catalogue Number: DSX400T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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