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

Model Number DSX1030S11F

Device Problem Material Integrity Problem (2978)

Patient Problem Pulmonary Emphysema (1832)

Event Date 12/01/2023

Event Type  Injury  

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 patient alleges that the unit was sprayed twice with ant killer or hairspray by her sister who has dementia.The first time it happened the unit was washed, and filters replaced.The second time it was sprayed they were "unsure" if the device got washed.The patient used the device and woke up with intense chest "spray".The patient went to the hospital and was told "their lungs were sticking together." the patient was diagnosed with emphysema.The patient is being treated with antibiotics and steroids.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REP DREAMSTATION ST30, DS
• 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: 18397421
• MDR Text Key: 331370047
• Report Number: 2518422-2023-37800
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial
• Report Date: 12/27/2023

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: DSX1030S11F
• Device Catalogue Number: DSX1030S11F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female