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

Model Number DSX1030T11C

Device Problems Degraded (1153); Moisture Damage (1405); Environmental Particulates (2930); Device Contamination with Chemical or Other Material (2944)

Patient Problems Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

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 really bad headaches and toothaches from using the affected device.Patient also states they experienced headaches.Medical intervention was not specified.The device was returned to the manufacturer on 07/26/2022 and is pending evaluation.Three attempts were made to gather additional information but were unsuccessful.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was previously 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 really bad headaches and toothaches from using the affected device.Patient also states they experienced headaches.Medical intervention was not specified.The device was returned to the manufacturer's quality product investigation laboratory for further investigation, 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 device was visually inspected.The external investigation found evidence of damage and contamination.There is unknown dust and dirt contamination present on all surfaces of the base unit and at the inlet where the filter would be and at the iso port entrance.The device returned without the accessory port flip door, sd card or filter.The device's error log was reviewed, and the manufacturer confirmed no errors were logged.An internal investigation was performed on the device.The manufacturer confirmed the device had no evidence of foam degradation.The manufacturer found evidence of moderate dust and dirt in the blower box, on the blower and on the blower impeller which was inconsistent with degraded sound abatement foam contamination.A keratin like substance was observed around the blower box outlet and was previously addressed in er 2243857 (v.01).There were mineral spots consistent with water ingress observed within the blower box and motor casing which was previously addressed in inv 1023.Pil is unable to directly address the symptoms outlined in the complaint.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION BIPAP ST
• 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 15208 ; 4125423300
• MDR Report Key: 17783034
• MDR Text Key: 323859334
• Report Number: 2518422-2023-23907
• Device Sequence Number: 1
• Product Code: MNS
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1030T11C
• Device Catalogue Number: DSX1030T11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1