MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fatigue (1849); Cough (4457); Wheezing (4463); Unspecified Respiratory Problem (4464)

Event Date 05/03/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a dreamstation 2 adv auto cpap contributed to wheezing, cough, hoarse voice, runny nose, shortness of breath, and lack of energy due to a dirty filter beginning (b)(6) 2022.The user was prescribed a 10 day course of antibiotics.There was no report of serious patient harm or injury.The device has not yet returned for evaluation.The manufacturer's investigation is ongoing.A final report will be submitted when the investigation has been completed.

Manufacturer Narrative

The manufacturer previously received information alleging a dreamstation 2 adv auto cpap contributed to wheezing, cough, hoarse voice, runny nose, shortness of breath, and lack of energy due to a dirty filter beginning january 2022.The user was prescribed a 10- day course of antibiotics.There was no report of serious patient harm or injury.The device was returned to the manufacturer for evaluation.The technician was able to power on the device using the returned power supply and power cord, confirm airflow, a known good, heated tube heats, and the heater plate heats.The technician determined the device was likely reset prior to the product investigation lab receipt due to it having 2407.9 machine hours and 0 blower and therapy hours.There were 2 instances of e-50 (err_daily_values_corrupt), a continue error, and 3 instances of e-400 (err_message_crc_failed), a continue error.These errors were not reproduced with continued usage and do not impact this investigation.Care orchestrator data was not available for download.During the investigation, the technician observed an unknown contaminant in the water tank.An unknown dust contaminant was observed on the ui panel, top enclosure, center enclosure, inlet of the blower box, blower, blower seal, and blower box.Hair-like particles were observed on the blower box and blower.An unknown dust contaminant was observed on the heater plate and bottom enclosure.The product investigation lab is unable to directly address the symptoms or complaints.

• Brand Name: DREAMSTATION 2 ADV AUTO CPAP 2
• 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: 14375140
• MDR Text Key: 291502962
• Report Number: 2518422-2022-12695
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female