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

Model Number RJPG500S16

Device Problems Overheating of Device (1437); Sparking (2595)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation go auto device's sparks were flying out from the ac cord inlet while the power cord was disconnected and reconnected.The sd card of the device was also overheating in a few seconds.The device was also starting properly and was not overheating if the sd card was not inserted.There was no report of serious harm or injury.The device was returned to a manufacturer service center for evaluation.The manufacturer could not confirm the customer's allegation.The manufacturer received one reboot error of the circuit board (e-83) and replaced the circuit board.During the evaluation of the device, the manufacturer also replaced the iso port, transition tube, blower boot, blower box top, inlet filter baffle, flow sensor seal, blower, and therapy circuit board.

• Brand Name: DREAMSTATION GO 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: 18063624
• MDR Text Key: 327247360
• Report Number: 2518422-2023-28751
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• 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: Lay User/Patient
• Device Model Number: RJPG500S16
• Device Catalogue Number: RJPG500S16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1