MAUDE Adverse Event Report: RESPIRONICS, INC. DS2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problems Degraded (1153); Patient Device Interaction Problem (4001)

Patient Problems Asthma (1726); Hypersensitivity/Allergic reaction (1907); Unspecified Respiratory Problem (4464); Dry Mouth (4485)

Event Date 10/06/2023

Event Type  Injury  

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 alleged latex of the device, running nose and very dry mouth, very horse, lots of mucus, clear in color related to a ds2adv auto cpap sound abatement foam.The patient reported 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 : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported this device under recall z-1973-2021.After further review, the manufacturer concluded the reported device is not under recall.In box b, describe an event or problem that should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleged latex of the device, running nose and very dry mouth, very horse, lots of mucus, clear in color related to a ds2adv auto cpap sound abatement foam.The patient reported medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The previous mdrs stated this event was a product problem only.This mdr corrects the event to a serious injury and updates the coding to accurately reflect customer reported event.Device not returned to manufacturer.

Event Description

The manufacturer received information alleging that the patient is allergic to something with the device.She has a runny nose, very dry mouth very horse, lots of mucus and clear in color.Additionally, the patient is allergic to latex, and she has asthma.The patient has been to the breathing doctor and got medications as medical intervention.The patient stated she uses johnson baby shampoo and washes daily the device daily as cleaning method.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DS2ADV 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: 17919158
• MDR Text Key: 325476890
• Report Number: 2518422-2023-26257
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• 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,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female