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

Model Number RGBX1030S20

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

Patient Problem Insufficient Information (4580)

Event Date 10/23/2023

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 manufacturer received information alleging patient passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously reported this device under recall z-1973-2021.After further review, the manufacturer concluded the reported device is not under recall.In section b5, describe an event or problem that should be reported as: the manufacturer received information alleging issues with a dreamstation st30 device that the patient passed away.There was no allegation that the device contributed to the death.Additional information has been requested regarding the details of the reported death.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In the section h6 medical device problem code has been corrected in this report.The section h7 remedial action initiated, and section h9 recall (z) number would not be applicable, which has been corrected in this report.

• 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: 18037890
• MDR Text Key: 326947722
• Report Number: 2518422-2023-28213
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,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: RGBX1030S20
• Device Catalogue Number: RGBX1030S20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1973-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death