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

Model Number FRX500S14

Device Problems Contamination (1120); Electrical /Electronic Property Problem (1198)

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

Event Date 11/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device serviced by third party service center.

Event Description

The manufacturer received information regarding a dreamstation auto.The device was returned to a third party service center.During visual inspection of the device, the power connector of the unit or the electronic board seems defective, and the unit cannot be powered on in order to collect the error log, error numbers, blower and machine hours, software version.In addition, the inspection found dust and dirt were observed inside the device.The device was scrapped.This report is being submitted for the power connector of the unit or electronic board seems defective, and the unit cannot be powered on.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.

• Brand Name: DREAMSTATION AUTO
• 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: 18343065
• MDR Text Key: 330783308
• Report Number: 2518422-2023-36079
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FRX500S14
• Device Catalogue Number: FRX500S14
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1