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

Model Number RJPG500S16

Device Problems Degraded (1153); Device Emits Odor (1425); Insufficient Flow or Under Infusion (2182)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

The reporter's phone number is (b)(6).H3 other text : 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 manufacturer received information alleging the flow abated and stopped in the end during use.A message "service required" was displayed on the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to a third party service center for evaluation.During the evaluation, the therapy pca software was confirmed to be version 1.1.6.The occurrence of onscreen "service required" was not duplicated.The error log revealed that e-4 had occurred.The error log was cleared and thereafter operation checking was performed.It was ensured no anomaly was present in the device.A life-related smell was observed, so the following parts were replaced: iso port, transition tube, blower bellows, blower boot, blower box top, inlet filter baffle, blower, flow sensor seal.The following were tests performed: overall checking, cleaning, and a functional test.

• 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: 18036141
• MDR Text Key: 326925018
• Report Number: 2518422-2023-28130
• 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
• Remedial Action: Recall
• 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: 09/10/2023
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1