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

Model Number DSX500T11C

Device Problem Degraded (1153)

Patient Problems Itching Sensation (1943); Blurred Vision (2137); Dizziness (2194)

Event Date 08/16/2021

Event Type  malfunction  

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 eyes blurry, back itching, dizziness.There was no report of patient harm or injury.The device was returned to the manufacturer¿s product investigation laboratory for investigation.The device was visually inspected by the manufacturer and found evidence of dust contamination on the blower outlet seal, evidence of water ingress to the blower box outlet.There was no evidence of sound abatement foam degradation.The device as powered on and provided flow.The device¿s downloaded event log was reviewed by the manufacturer and found 0 errors logged.The manufacturer concludes the device had evidence of dust, liquid ingress contamination.There was no evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17487736
• MDR Text Key: 320905545
• Report Number: 2518422-2023-18932
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• 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: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1