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

Model Number DSX500T11

Device Problem Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Unspecified Respiratory Problem (4464)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

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 patient alleges sinus infections.Patient stated " the problem is my sleep apnea was uncontrolled and i went into atrial fibrillation by the end of august and went undiagnosed until october 5th when i had a cardioversion.My heart was stable until (b)(6) 2023, when i woke up back in atrial fibrillation and had to undergo another cardioversion.I plan to have an ablation procedure to try to prevent another episode of atrial fibrillation.Prior to losing the use of the c-pap i had never been diagnosed with atrial fibrillation".Medical intervention was required by the patient.The patient had a cardioversion.The patient reported using an ozone-based disinfection device for a period of one year.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported information 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 patient alleges sinus infections.Patient stated " the problem is my sleep apnea was uncontrolled and i went into atrial fibrillation by the end of august and went undiagnosed until october 5th when i had a cardioversion.My heart was stable until (b)(6) 2023, when i woke up back in atrial fibrillation and had to undergo another cardioversion.I plan to have an ablation procedure to try to prevent another episode of atrial fibrillation.Prior to losing the use of the c-pap i had never been diagnosed with atrial fibrillation".Medical intervention was required by the patient.The patient had a cardioversion.The patient reported using an ozone-based disinfection device for a period of one year.On the previously submitted report in section b product problem was selected in error.It is now corrected to be an adverse event on 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: 17683193
• MDR Text Key: 322637187
• Report Number: 2518422-2023-21706
• 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

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11
• Device Catalogue Number: DSX500T11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2016
• 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): Life Threatening