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

Model Number RGBX1030S20

Device Problem 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 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

Device not returned to manufacturer.

• 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: 18054511
• MDR Text Key: 327131312
• Report Number: 2518422-2023-28235
• 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
• Type of Report: Initial

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: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death