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

Model Number NDX500S15

Device Problems Contamination (1120); Degraded (1153)

Patient Problem Embolism/Embolus (4438)

Event Date 11/21/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a blood clot.The patient was hospitalized in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, and mechanical ventilator devices.The manufacturer previously received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop a blood clot in brain.The patient was hospitalized in response to the reported event.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally observed that unknown dust contamination inside the blower box at the air inlet, top enclosure, front panel, bottom enclosure, rear panel.A keratin like substance was observed on the blower box.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found one error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation.The manufacturer observed dust contamination and keratin substances are consistent with being from an external source.Section h6 type of investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION AUTO CPAP, ND
• 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: 12435353
• MDR Text Key: 270215622
• Report Number: 2518422-2021-03695
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959027206
• UDI-Public: 00606959027206
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NDX500S15
• Device Catalogue Number: NDX500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Patient Outcome(s): Hospitalization