MAUDE Adverse Event Report: BULGARIAN DRUG AGENCY, MINISTRY OF HEALTH DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Pulmonary Dysfunction (2019); Unspecified Respiratory Problem (4464)

Event Date 01/12/2024

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 device, airway, tubing and chamber.The patient alleges a lung infection.The patient required no medical intervention.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 : the device has not been returned to the manufacturer for analysis.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BULGARIAN DRUG AGENCY, MINISTRY OF HEALTH; BU
• Manufacturer (Section G): BULGARIAN DRUG AGENCY, MINISTRY OF HEALTH; BU
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18700759
• MDR Text Key: 336425122
• Report Number: 2518422-2024-07270
• 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
• Type of Report: Initial

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2019
• 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