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

Model Number DSX900H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Stroke/CVA (1770); Cancer (3262); Convulsion/Seizure (4406)

Event Date 02/09/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused the patient to have seizures, strokes, and brain tumor.The medical intervention that the patient received in response to the event is currently unknown.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer also received additional information alleging the particles in the device and airway.

Manufacturer Narrative

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 a bilevel positive airway pressure (bipap) device's sound abatement foam became degraded and caused the patient to have seizures, strokes, and brain tumor.The medical intervention that the patient received in response to the event is currently unknown.The manufacturer also received additional information alleging particles in the device and airway.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, evidence of sound abatement foam degradation or breakdown was not observed in the base unit.No unusual sound or odor was observed coming from the device during operational testing.In secondary findings, slight brown or gray-colored unknown contamination was observed on and around the iso port.Observed an unknown gray or brown contamination at the air input of the blower box at the filter location.Observed minor, unknown brown-colored contamination and fibrous contamination on the top enclosure under the right-side accessory door.Observed a light gray or brown non-uniform film of unknown contamination throughout the inside of the enclosure.This film can be smudged.Observed an unknown white (dust-like) contaminant on the top of the blower motor and on the inner rim of the bottom of the blower motor.Observed dust-like and other unknown contamination on the blower outlet seal.Light gray or brown dust-like contamination was present at the bottom of the blower box.Observed black contamination at the blower seal of the blower box that is consistent with the keratin contamination observed.There is no visible damage or functionality failure on the device, which suggests that the source of contamination was external to the device.  the device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes that there is no evidence of sound abatement foam degradation or breakdown.Confirmed the presence of multiple contaminants that are not consistent with degraded sound abatement foam, likely from an external source.Unable to address the patient's symptoms specified.

• Brand Name: DREAMSTATION BIPAP
• 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: rosko melissa ; 6501 living place; pittsburgh, PA 15206 ; 7243512041
• MDR Report Key: 13720102
• MDR Text Key: 286923472
• Report Number: 2518422-2022-09192
• Device Sequence Number: 1
• Product Code: BZD
• 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
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900H11C
• Device Catalogue Number: DSX900H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• 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