MAUDE Adverse Event Report: RESPIRONICS, INC DREAMSTATION BIPAP ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1030H11C

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Dyspnea (1816); Myocardial Infarction (1969); Cough (4457); Eye Pain (4467)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

A user contacted the manufacturer regarding the sound abatement foam correction/removal for their bipap device.The patient alleges to have had strokes and heart attacks; eye irritation.There is no report of medical intervention being required.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an issue regarding the sound abatement foam for the bipap device.The manufacturer received additional information 08/04/2022 alleging device noise; cough; difficulty breathing/short of breath.Section h6 has been updated to include the appropriate coding.

Manufacturer Narrative

The manufacturer previously 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 additional information 11/28/2022 alleging particles found in device; congestive heart failure; diabetes; has had heart attack and stroke.Section b7 has been updated to add relevant history.The manufacturer previously reported this mdr as an adverse event.The manufacturer has determined this to be a product problem based on the manufacturer's clinical expert conclusion that the patient's symptoms of congestive heart failure; diabetes; has had heart attack and stroke is not related to the device.

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 bi pap device's sound abatement foam.The patient alleged to experience congestive heart failure, diabetes, had a heart attack, had a stroke and was in the emergency room.Seeing particles in the device and there was no air coming out from the device.There was no medical intervention required by the patient.The reported event of congestive heart failure, diabetes, had a heart attack, had a stroke, was in the emergency room 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.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 h4 updated in this report.( in initial mdr the mfg.Date of the device was wrongly captured).Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

Manufacturer Narrative

In previous report, the manufacturer reported the incorrect information in section b1 by marking as adverse event.After review, it was determined that this options was inadvertently selected in section b1.No adverse event has occured to the patient.The following correction has been updated in this report.Section b1 has been updated to reflect as product problem.Section h1 has also been updated to reflect the malfunction.Section h6 health impact code has also been updated to reflect the no health consequences or impact.

• Brand Name: DREAMSTATION BIPAP ST30
• 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: 13980636
• MDR Text Key: 288469608
• Report Number: 2518422-2022-12379
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• 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,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030H11C
• Device Catalogue Number: DSX1030H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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