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

Model Number CAX500H12

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Pulmonary Embolism (1498); Asthma (1726); Pulmonary Edema (2020)

Event Date 07/03/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam and caused the patient to develop pulmonary embolisms, asthma and abscess in trachea.The patient did receive medical intervention of thyroidectomy and emergency medical intervention for blocked airway.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res (b)(4).

Manufacturer Narrative

The manufacturer previously received information alleging an issue related to the device's sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.In initial reports section b5 mentioned incomplete, correct b5 should be: 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 multiple acute pulmonary embolisms, constant pulmonary embolisms, asthma, fluid in lungs, thyroidectomy, abscess in trachea that blocked airway, and black particles in mask, tubing, and filter.Medical intervention of thyroidectomy and emergency medical intervention for a blocked airway was reported.The device was returned to the manufacturer's product investigation laboratory for further investigation.The device was evaluated, and the evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer observed the dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout device enclosure, and airpath, suggesting a source external to the device.Evidence of water ingress on the blower and blower box was found.Slight black contamination at the blower seal of the blower box is consistent with the keratin contamination observed.The internal aspect of the device was inspected.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer's allegation and that there was no evidence of sound abatement foam degradation or breakdown observed in the base unit.The manufacturer confirmed the presence of contamination in the airpath.Section d8, d9, h2, h3 were updated in this report.Section h6 health effect - clinical code, type of investigation, investigation findings, and investigation conclusions have been updated.In section d4 unique identifier (udi) number has been corrected / updated.

• 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: 13102705
• MDR Text Key: 282899579
• Report Number: 2518422-2021-08765
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500H12
• Device Catalogue Number: CAX500H12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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): Required Intervention
• Patient Sex: Male