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

Model Number DSX500H11C

Device Problem Degraded (1153)

Patient Problems Apnea (1720); Dyspnea (1816); Low Oxygen Saturation (2477); Convulsion/Seizure (4406); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/24/2023

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 alleging difficulty breathing/short of breath, patient lungs don't expand, brain has no oxygen, brain infection, seizure, bi polar and schizophrenic, sleep issues.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

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 difficulty breathing/short of breath, patient lungs don't expand, brain has no oxygen, brain infection, seizure, bi polar and schizophrenic, sleep issues.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.Correction to section h: type of reported complaint changed to product problem.

Manufacturer Narrative

In previous report, the manufacturer received information alleging difficulty breathing/short of breath, patient lungs don't expand, brain has no oxygen, brain infection, seizure, bi polar and schizophrenic, sleep issues.There was no medical intervention required by the patient.After further information it was determined the alleged symptoms is a serious injury but not related to the device.In this report section b and h has been updated/corrected.

Manufacturer Narrative

On previously submitted report, box b: "adverse event or product problem" was incorrect.

• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16271672
• MDR Text Key: 308466275
• Report Number: 2518422-2023-03289
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• 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
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2019
• 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; Hospitalization