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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Sore Throat (2396)

Event Date 01/20/2022

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 cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused the patient to have high blood pressure, nasal irritation, sore throat, fever and headache.The medical intervention that the patient received in response to the event is currently unknown.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.  additional information was received and section b5 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 received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.The patient alleged to experience a headache, sore throat,nasal irritation,fever and elevated blood pressure.He also alleged visualization of particles in the device.There was no medical intervention required by the patient.The reported event of headache, sore throat,nasal irritation,fever and elevated blood pressure and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.  the device has not yet returned to the manufacturer for evaluation.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(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.The manufacturer previously not captured visualization of particles in section b5 and it has been updated in this report.

• Brand Name: DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 muury ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 muury ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburg, PA 15206 ; 2673970028
• MDR Report Key: 15330938
• MDR Text Key: 299035122
• Report Number: 2518422-2022-58266
• 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
• Report Date: 06/05/2023

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: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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
• Patient Outcome(s): Other