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

Model Number DSX900S11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Dyspnea (1816); Nausea (1970); Rash (2033); Vomiting (2144); Cough (4457); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam.There was no report of patient harm/injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer was initially 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 particles in airway in tubing/chamber, nausea, vomiting, rash, cough, and difficulty breathing/shortness of breath related to a bipap device's sound abatement foam.There was no report of patient harm or injury.Section b5 has been corrected and should be reported as: the manufacturer was initially 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 particles in airway in tubing/chamber, nausea, vomiting, rash, cough, and difficulty breathing/shortness of breath related to a bipap device's sound abatement foam.The device was returned to the manufacturer's product investigation laboratory for investigation.An external and internal visual inspection of the device was completed by the manufacturer and found an unknown dust contaminant inside the air inlet of the blower box, on the rear panel, top enclosure, blower, blower seal, and blower box.Evidence of liquid ingress was observed on the blower.Hair-like particles were observed on the blower and blower box.The manufacturer found no evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes that there was presence of dirt contamination in airpath and no evidence of sound abatement foam degradation found within the device.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• 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: 13040193
• MDR Text Key: 282506709
• Report Number: 2518422-2021-08328
• 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
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX900S11
• Device Catalogue Number: DSX900S11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 12/18/2021
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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