MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AUTOSV H, DS; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX900H11

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Dyspnea (1816); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Tract Infection (2420)

Event Date 05/01/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and the patient developed sinus infections and chronic obstructive pulmonary disease (copd).The patient did require medical intervention in the form of prescribed antibiotics.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.The end user indicated ozone or other unapproved cleaning and disinfection method was used.This action was reported to fda per 21 cfr part 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.The patient has severe central apnea and cheyne-stokes.Section g3 is updated in this follow-up.In section h6, health effect - clinical code is updated.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Section b5 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 visualization of black particles related to a bipap device's sound abatement foam.Patient alleged to developed sinus infections, chronic obstructive pulmonary disease (copd), enlarged spleen, higher apnea-hypopnea index(ahi) and higher periodic breathing events.Patient used oxygen bar to reduce ahi and also alleged of having severe central apnea and cheyne-stokes.The patient did require medical intervention in the form of prescribed antibiotics.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 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 updated.

• Brand Name: DREAMSTATION BIPAP AUTOSV H, DS
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 12322141
• MDR Text Key: 266588301
• Report Number: 2518422-2021-02589
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

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: DSX900H11
• Device Catalogue Number: DSX900H11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/14/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 02/21/2022; 05/19/2023
• Supplement Dates FDA Received: 09/03/2021; 04/25/2023; 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• 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
• Patient Age: 67 YR
• Patient Sex: Male