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

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Rash (2033); Vomiting (2144); Dizziness (2194); Unspecified Respiratory Problem (4464); Unspecified Gastrointestinal Problem (4491); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

The manufacturer received voluntary medwatch (mw5104713) alleging an issue related to a continuous positive airway pressure (cpap) device.The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap and mechanical ventilator devices.The manufacturer received information alleging chronic headaches, upper airway irritation, chest pressure, skin rashes/bumps/itching, inflammatory, nausea, vomiting, bloating, dizziness, sinus congestion, sinus drainage.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

On the previously manufacture report d1 was incorrect.In this report d1 section has been corrected and updated.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Section b5 in previous report was incomplete and 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 received information alleging an issue related to a cpap device's sound abatement foam.Patient was alleging chronic headaches, upper airway irritation, chest pressure, skin rashes/bumps/itching, inflammatory, nausea, vomiting, bloating, dizziness, sinus congestion, sinus drainage, blood in machine and in saliva.In response to event patient have been to multiple doctors over to find the diagnosis, and was unable to diagnose the symptoms.There was no report of serious or permanent patient harm or injury.Since there is no customer information, the manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.Section h6 health effect - clinical code which was missed in previous report was captured.Section h6 type of investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION
• 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: 15430929
• MDR Text Key: 302935222
• Report Number: 2518422-2022-81045
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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