MAUDE Adverse Event Report: RESPIRONICS, INC. DS2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number BLX520H15C

Device Problem Degraded (1153)

Patient Problems Sneezing (2251); Unspecified Respiratory Problem (4464)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an event 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 greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device is not related to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.Box b: adverse event or product problem; describe event or problem should state, "the manufacturer received information alleging visualization of greyish particles in the device waterbank.The patient has contacted mediq (the distributor) with this complaint but does not feel he is taken seriously.The patient reports visualization of gray flakes several times in the morning even when usage was short.The patient also reports being awaken by a persistent runny nose with subsequent sneezing.The patient's device has been exchanged a few times.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.".

• Brand Name: DS2 ADV AUTO CPAP
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18980224
• MDR Text Key: 338621075
• Report Number: 2518422-2024-15085
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959062818
• UDI-Public: 00606959062818
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BLX520H15C
• Device Catalogue Number: BLX520H15C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1