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

Model Number DSX500T11C

Device Problem Degraded (1153)

Patient Problems Chest Pain (1776); Pneumonia (2011); Cough (4457)

Event Date 07/16/2021

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 alleging a strange smell through the breathing tube.Patient also alleges cough and chest pain on their left side.Patient alleges going to hospital and discovering they have a bacterial infection in the left lung.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 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 a strange smell through the breathing tube.Patient also alleges cough and chest pain on their left side.Patient alleges going to hospital and discovering they have a bacterial infection in the left lung.Medical intervention was not specified.The manufacturer reported a product problem in the previous report; after further assessment, the reported event was concluded to be a serious injury and corrected in the below sections.Section(s) have been corrected to reflect adverse event.Section has been corrected to reflect serious injury.Section health effect clinical code and impacts codes have been updated in this report.

• Brand Name: DREAMSTATION 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: 17852420
• MDR Text Key: 324704059
• Report Number: 2518422-2023-25141
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 10/02/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2017
• 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