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

Model Number DSX900T11C

Device Problem Degraded (1153)

Patient Problem Tinnitus (2103)

Event Date 09/01/2022

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 bipap device's sound abatement foam became degraded and caused tinnitus.The patient did not report to receive medical intervention.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 received information alleging an issue related to a bipap device's sound abatement in which foam became degraded and caused tinnitus.The patient did not report to receive medical intervention.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 bipap device's sound abatement in which foam became degraded and caused tinnitus.The patient has alleged to seein particles in the tubing/chamber and airway of the device.The patient did not report to receive medical intervention.There was no medical intervention required by the patient.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 bipap device's sound abatement in which foam became degraded and caused tinnitus.The patient has alleged to seein particles in the tubing/chamber and airway of the device.The patient did not report to receive medical intervention.The reported event of tinnitus 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, no further investigation can be performed.If any additional information is received, a follow up report will be filed. .

• Brand Name: DREAMSTATION BIPAP AUTOSV
• 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: 15380091
• MDR Text Key: 299477189
• Report Number: 2518422-2022-80332
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• 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: 05/09/2023

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: DSX900T11C
• Device Catalogue Number: DSX900T11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 12/29/2022; 05/08/2023
• Supplement Dates FDA Received: 01/04/2023; 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2020
• 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