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

Model Number DSX520T11C

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pneumonia (2011); Cough (4457)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a ds2adv auto cpap device's sound abatement foam.The manufacturer received information alleging that water to pour into lungs which causes pneumonia, cough, sputtering.There was no medical intervention 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

H3 other text : device has not yet been returned for evaluation.

Manufacturer Narrative

In previous report, "section b" "describe event or problem" that the manufacturer received information alleging an issue related to a ds2adv auto cpap device's sound abatement foam.The manufacturer received information alleging that water to pour into lungs which causes pneumonia, cough, sputtering.There was no medical intervention required by the patient.And "section h" "(device) problem code grid" were incorrect.In this report, "section b" "describe event or problem" that the manufacturer received information alleging an issue related to a ds2adv auto cpap device.The manufacturer received information alleging that water to pour into lungs which causes pneumonia, cough, sputtering.There was no medical intervention required by the patient.And "section h" "(device) problem code grid" has been updated or corrected.

Manufacturer Narrative

In previous report the manufacturer received information alleging an issue related to a ds2adv auto cpap device's sound abatement foam.The manufacturer received information alleging that water to pour into lungs which causes pneumonia, cough, sputtering.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.After receiving further information from the patient, it is determined that the initial report should have been filed as product problem only.In this report, "box b" "adverse event/product problem", "outcomes attributed to ae" and "box h" "type of reported complaint", "(device) problem code grid" and "health impact grid" has been updated or corrected.

• 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: 18158925
• MDR Text Key: 328386256
• Report Number: 2518422-2023-30747
• 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
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male