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

Model Number DSX400T11

Device Problem Degraded (1153)

Patient Problems Abdominal Pain (1685); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging an issue related to particles in cpap device humidifier and chamber.There was no report of patient 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 manufacturer received information alleged visualization of particles.There was no report of serious or permanent 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 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 were no errors found.   the manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.

Manufacturer Narrative

Additional information was received on march 05, 2024, and section h10 should be reported as: 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 an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging that the device made a squealing noise, and they noticed black particle matter between the chamber and humidifier.Patient opened the device and noticed dust and grease inside the unit.The patient reported that they took the pump apart and split the top part of the pump open, and there was gray particle matter with oily, greasy material inside of it.Additional information is received about alleged lung disease, dx with dvts and pes in the lung, sphincter of oddi dysfunction (muscular valve in the digestive tract), abdominal pain, and intestinal damage.No medical intervention or treatment was reported.Section b1 was corrected to adverse event (product problem was checked in previous mdr) section b2 was corrected to other serious or important medical events.(previously it was blank) section h1 was changed from malfunction to serious injury.In this report, health effect - impact code and health effects: clinical codes has been updated.

• Brand Name: DREAMSTATION CPAP PRO
• 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: 13588064
• MDR Text Key: 287120036
• Report Number: 2518422-2022-06611
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400T11
• Device Catalogue Number: DSX400T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/03/2023; 03/25/2024
• Supplement Dates FDA Received: 04/11/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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
• Patient Outcome(s): Other