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

Model Number DSX900H11C

Device Problem Degraded (1153)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Dyspnea (1816)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bicpap device's sound abatement foam became degraded and caused a heart attack a week ago and difficulty breathing.The patient did not 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 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 previously received information alleging an issue related to the device's sound abatement foam.The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused a heart attack a week ago, chest pain and difficulty breathing.The patient did not receive medical intervention.Section h6 was updated with the appropriate health effect - clinical code.

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 foam.The patient alleged to experience a heart attack a week ago and difficulty breathing.There was no medical intervention required by the patient.The reported event of heart attack 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.The patient has swapped out the device at the distributor and at this time, no further investigation can be performed.If any additional information is received, a follow up 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.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14270425
• MDR Text Key: 290775320
• Report Number: 2518422-2022-16624
• 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
• Report Date: 07/07/2023

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 Model Number: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/03/2022
• Supplement Dates Manufacturer Received: 02/11/2022; 06/07/2023
• Supplement Dates FDA Received: 09/30/2022; 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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