MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2 AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Device Emits Odor (1425); Appropriate Term/Code Not Available (3191)

Patient Problem Choking (2464)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging that patient was asleep and woke up choking and mask was full of smoke and smell was so bad that he could taste the burning smell.Patient shut the machine off and unplugged the machine.The patient also states that they could smell the smoke smell in the entire bedroom.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: DREAMSTATION2 AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19174397
• MDR Text Key: 341012662
• Report Number: 2518422-2024-21907
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2022
• 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