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

Model Number DSX700T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Nausea (1970); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Ear or Labyrinth Problem (4474)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain bipap and mechanical ventilator devices.The manufacturer received information alleging nasal/ throat irritation, shortness of breath, nausea, lightheaded, dizziness, headaches, blurry vision, high blood pressure, vomiting, ears hurting, weakness and feels unstable.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

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 nasal/ throat irritation, shortness of breath, nausea, lighthead, dizziness,headaches, blurry vision, high blood pressure, vomiting, ears hurting, weakness and feels unstable and she heard a whoosing sound.There was no report of serious or permanent harm or injury.Additional information was received and added to the report.The device was returned to the manufacturer's service center on (05/12/2023) for further evaluation.The device was evaluated on (06/07/2023).There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected and there was findings are beige contaminant on the front panel, air inlet and water ingress in blower box.The manufacturer applied power to the device and verified airflow.The device's downloaded logs were reviewed by the manufacturer and there were no errors.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section h6 were updated in this report.

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 nasal/ throat irritation, shortness of breath, nausea, lighthead, dizziness, headaches, blurry vision, high blood pressure, vomiting, ears hurting, weakness and feels unstable related to a bipap 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.

• Brand Name: DREAMSTATION AUTO BIPAP
• 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: 15251077
• MDR Text Key: 301907932
• Report Number: 2518422-2022-72894
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11C
• Device Catalogue Number: DSX700T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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