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

Model Number DSX500T11C

Device Problems Contamination (1120); Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/14/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging of a thermal event to the power cord or power supply of a continuous positive airway pressure (cpap) device.The user reported experiencing "burning" to the side of the face.There was no report of serious or permanent injury, and no medical intervention was reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer has not received the devices for investigation.Despite multiple requests, no device has been returned.If further information becomes available, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

Manufacturer Narrative

The manufacturer previously received information alleging of a thermal event to the power cord or power supply of a continuous positive airway pressure (cpap) device.The user reported experiencing "burning" to the side of the face.There was no report of serious or permanent injury, and no medical intervention was reported.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected internal and external parts of the device.Exterior investigation found unknown dust/dirt contamination present on all surfaces of the base unit.The device did not return with an accessory port flip door, sd card, or filter.There was an unknown dust contaminate present at the air inlet where the filter would be and at the iso port entrance.There was an unknown grey residue around the exterior of the iso port.Interior investigation found unknown debris in the tracks of the ui panel.There was an unknown white dust contamination found on the bottom enclosure, blower box housing, blower motor, blower impeller, and rear panel o-ring.Secondary findings included an unknown dust/dirt contamination and fibers found on the blower casing/impeller and blower box was inconsistent with degraded sound abatement foam contamination.The presence of contamination throughout the airpath suggests a source external to the device.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found one error codes.The manufacturer verified the power cable and airflow using good power supply.The manufacturer concludes there was no evidence of sound abatement foam degradation/breakdown was observed in this device.Sections h7 and h9 were missed to capture in the previous report, which have been updated in this report.

• 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 ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14454971
• MDR Text Key: 292156887
• Report Number: 2518422-2022-01956
• 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,Followup,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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 Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1