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

Model Number DSX500H11

Device Problems Degraded (1153); Moisture or Humidity Problem (2986)

Patient Problems Headache (1880); Unspecified Respiratory Problem (4464)

Event Date 09/12/2023

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 visualization of particles in the air path.The patient alleges congestion and headache.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The patient was contacted and confirmed seeing particles in the tank and moisture in the hose.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text: device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported information 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 congestion and headache.The patient did not state whether medical intervention was required."other" was inadvertently selected under adverse event on the initial report.A pms clinical expert review made a determination based on information available at the time of this review, that the allegations do not constitute a serious injury, therefore the adverse event entry of "other" has been removed.The device has not yet been returned to the manufacturer for evaluation.The customer responded via e-mail on 09/20/2023 and stated the device is available to be returned for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17869420
• MDR Text Key: 325365771
• Report Number: 2518422-2023-25062
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Device Catalogue Number: DSX500H11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other