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

Model Number DSX500H11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Nausea (1970); Ulcer (2274)

Event Date 09/17/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging,she got a letter and is having all of the systems that she saw on the letter.She has sores in her nose and is nauseated.Particle's in tubing/chamber related to a cpap device's sound abatement foam.There was no report of 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 received information alleging visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.  repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.  section h6 updated in this report.

Manufacturer Narrative

In previous report section h10 is incomplete.It has been captured completely in this report.Section h10 should be previously 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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged alleging,she got a letter and is having all of the systems that she saw on the letter.She has sores in her nose and is nauseated.Particles in tubing/chamber.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 but manufacturer observed evidence of water ingress to the blower and unit is scrapped due to age.Section h6 updated in this report.

• 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: 14403930
• MDR Text Key: 291715008
• Report Number: 2518422-2022-18304
• 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,Followup
• Report Date: 08/09/2023

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: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 05/15/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 06/03/2022
• Supplement Dates FDA Received: 03/15/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2015
• 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 Sex: Female