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

Model Number RJPXH

Device Problem No Display/Image (1183)

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

Event Date 02/07/2024

Event Type  malfunction  

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 a black screen and a burnt smell.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint for the burnt smell was not confirmed.It was confirmed that the screen display occasionally got black and black the moment the therapy button was pressed and no airflow was delivered.However, when a load was applied to the connector part to connect to the humidifier by such as twisted with fingers, airflow stopped and the screen turned black.Additional it is possible that a semi-disconnection or contact failure occurred around the connector of the heated tube.However, the cause was not identified.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19112108
• MDR Text Key: 340370436
• Report Number: 2518422-2024-19678
• 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: Company Representative
• Reporter Occupation: Other Health Care 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: Health Professional
• Device Model Number: RJPXH
• Device Catalogue Number: RJPXH
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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