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

Model Number DSX1030H11C

Device Problem Degraded (1153)

Patient Problem Convulsion/Seizure (4406)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused a patient to develop seizures.There is no report of the medical intervention that the patient has received at this time.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

Section b1 is updated in this report.(in follow up 1 report the section b1 was wrongly captured).

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 parkinson's disease or seizures.There was no medical intervention required by the patient.The reported event of parkinson's disease or seizures 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 h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

Manufacturer Narrative

The manufacturer previously submitted mdr 2518422-2021-07137-2.

• 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: 12856822
• MDR Text Key: 281134865
• Report Number: 2518422-2021-07137
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959045590
• UDI-Public: 00606959045590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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