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

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Sinus Perforation (2277); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

Device not returned.

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 from patient alleging they are experiencing difficulty breathing, cough and chest congestion.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 received information from patient experiencing sinus infection, cough, flu with chest congestion and difficulty breathing.After further review, the manufacturer concluded it as serious injury.In box b, product problem was updated to adverse event and product problem and describe event or problem should be reported as: 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 previously received information alleging issue related to a cpap device's sound abatement foam.The patient has alleged to sinus infection, cough, flu with chest congestion and difficulty breathing.The reported events of sinus infection, cough, flu with chest congestion and difficulty breathing of the patient and its reported severity was reviewed by the manufacture's clinical expert.These events are assessed at related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In box h, type of reported complaint and health impact code was updated to reflect serious injury.

• 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: 16628604
• MDR Text Key: 312144206
• Report Number: 2518422-2023-07797
• 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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention