MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION ST30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number GBX1030S20

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2023

Event Type  Death  

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 patient has passed away.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.

Manufacturer Narrative

In this report, box h has been updated/corrected.

Manufacturer Narrative

Initial report was submitted as a part of uno recall device, the device is not under the uno recall.Correct event description should be - the manufacturer received information regarding a rental, dreamstation st30.The patient has passed away.The manufacture's investigation is ongoing.A follow up report will be submitted.In this report box h has been updated/corrected.

• Brand Name: DREAMSTATION ST30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 18525648
• MDR Text Key: 333030924
• Report Number: 2518422-2024-02854
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102465
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GBX1030S20
• Device Catalogue Number: GBX1030S20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 12/20/2023; 12/20/2023
• Supplement Dates FDA Received: 01/19/2024; 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2023
• 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
• Patient Outcome(s): Death