MAUDE Adverse Event Report: RESPIRONICS, INC. RENTAL, 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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2024

Event Type  Death  

Manufacturer Narrative

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 an issue related to a cpap device's sound abatement foam.The patient has alleged to death.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

In this report the (device) problem code grid (0) has been corrected and updated.

Manufacturer Narrative

The manufacturer was previously 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 previously received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to death.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.In this report the describe event or problem, remedial action init (rfb), recall (z) number (rfb) has been corrected and updated.

Event Description

The manufacturer was contacted in reference to the dreamstation st30 device.The patient has alleged to death.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: RENTAL, 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: 18628211
• MDR Text Key: 334366497
• Report Number: 2518422-2024-05511
• 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: 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RGBX1030S20
• Device Catalogue Number: RGBX1030S20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/25/2024; 01/25/2024
• Supplement Dates FDA Received: 03/21/2024; 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2022
• 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