MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP ST30; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX1030S11

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Cancer (3262); Unspecified Heart Problem (4454)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap device's sound abatement foam became degraded and caused a heart condition and cancer.The patient did not report to receive any medical intervention.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 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 bipap device's sound abatement foam became degraded and caused a heart condition, cancer and shortness of breath.The patient did not report to receive any medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Section h6 was updated with the appropriate health effect - clinical code as well as the type of investigation, investigation findings and investigation conclusions.

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 that they need device due to heart condition ,cancer, difficult to breath, emphysema and lightheadedness.The reported event to be listed as past medical history which occured before device usage.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.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 b7 updated as per additional information.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 ST30
• 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: 13237186
• MDR Text Key: 283685045
• Report Number: 2518422-2022-00643
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092818
• 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: 08/09/2023

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: DSX1030S11
• Device Catalogue Number: DSX1030S11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 08/03/2023
• Supplement Dates FDA Received: 09/26/2022; 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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