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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Rash (2033)

Event Date 06/30/2021

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 rash/burn on face.Ther was no report of serious or permanent patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.An external visual inspection of the device was completed by the manufacturer and found cracked rear panel, a minor amount of beige dust or dirt contaminate, and fiber contaminate on the outer panels, surface cracks, crevasses, in and around the air inlet area, in the air inlet canal, around the sd card slot area, around the modem area, and around the outlet port.The inside of the outlet port contained some small and moderate fiber or hair contaminate.The rim of the outlet port contained a tiny black spec contaminate.An internal visual inspection of the device was completed by the manufacturer and found a minor amount of beige dust or dirt contamination on the top of the blower box, near the air intake area, and blower box chimney.Pil removed the blower box lid to find that the top of the bower contained a minor amount of beige dust or dirt contaminate.A moderate amount potential mineral deposits on the bottom of the blower and the internal bottom of the blower box.The outside of the blower box had a moderate chunk of plastic missing from the corner under the filter intake side.The manufacturer found evidence of sound abatement foam degradation.The device's downloaded event log was reviewed by the manufacturer and found 4 errors.The device was applied power and the device operated properly.The manufacturer concludes multiple contaminations of dust, dirt, fiber, hair, black spec, found were external to the device.The manufacturer concludes evidence of sound abatement foam degradation.

• Brand Name: DREAMSTATION 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: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16953333
• MDR Text Key: 315468867
• Report Number: 2518422-2023-11570
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• 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