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

Model Number DSX500H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Convulsion/Seizure (4406); Cough (4457)

Event Date 01/10/2022

Event Type  malfunction  

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 seizures and a cough.There is no report of the medical intervention that the patient has received at this time.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. a correction to b5 was made and 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, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged to develop seizures and a cough.There is no report of the medical intervention that the patient has received at this time.The device was returned to the product investigation laboratory for further evaluation.   the device was evaluated.The internal and external aspect of the device was inspected.The device powered on and airflow was confirmed.There were no errors found.During the investigation, the manufacturer observed an unknown contaminant on the sd module flip doors, top enclosure, on the iso port of the rear panel, bottom enclosure, and inside the air inlet of the blower box.An unknown dust contaminant was observed on the front panel.An unknown contaminant was observed on the o-ring of the rear panel and the rear panel.An unknown dust contaminant was observed on the bottom enclosure.An unknown contaminant consistent with mineral deposits and liquid ingress was observed on the blower cap, blower, blower seal, and blower box.A keratin-like substance was observed on the blower box outlet.Evidence of sound abatement foam degradation/breakdown was not observed.The manufacturer concludes that they could not confirm the customer's allegation and there was no visible foam degradation.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.

• 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 ; 2673970028
• MDR Report Key: 13497238
• MDR Text Key: 285325599
• Report Number: 2518422-2022-03778
• 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
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2017
• 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): Other