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

Model Number CAX501T12C

Device Problem Degraded (1153)

Patient Problems Burning Sensation (2146); Sore Throat (2396); Fluid Discharge (2686)

Event Date 10/13/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing a sore throat, runny nose and a burning sensation going down the body.There was no report of serious patient harm or injury.There was no medical intervention required by the patient.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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual finding to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were 1 error found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation. .

Manufacturer Narrative

In the previous follow-up report (mdr 2518422-2022-69162-1), section h10 was incorrectly captured, it has been corrected in this report to reflect the correct information.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 to experiencing a sore throat, runny nose and a burning sensation going down the body.There was no report of serious or permanent harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer's service center for further evaluation.The device was evaluated.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There was one error [error # 193] found.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit scrapped.

• Brand Name: DREAMSTATION EXPERT
• 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; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15176991
• MDR Text Key: 304275930
• Report Number: 2518422-2022-69162
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

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: CAX501T12C
• Device Catalogue Number: CAX501T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 02/16/2023; 02/16/2023
• Supplement Dates FDA Received: 04/19/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• 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