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

Model Number DSX500S11F

Device Problems Failure to Deliver (2338); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging the device's blower is no longer working on the machine.They have tried unplugging and plugging the device back in, as well as turning the machine on and off.The device could not be fixed.The patient is severely disabled and relies on the machine 24/7.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

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported an event stating the device's blower is no longer working on the machine.They have tried unplugging and plugging the device back in, as well as turning the machine on and off.The device could not be fixed.The patient is severely disabled and relies on the machine 24/7.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.This complaint has been reviewed and it has been determined that based on information available at the time of this review, that the complaint is not reportable to any regulatory authorities.There is no report of serious patient harm or injury associated with this notification and there is no report of medical intervention.

• 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: 18012678
• MDR Text Key: 326628220
• Report Number: 2518422-2023-27879
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11F
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1