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

Model Number CAX500T12C

Device Problem Degraded (1153)

Patient Problems Stroke/CVA (1770); Numbness (2415)

Event Date 08/19/2019

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused a stroke and numbness on the right side.The patient did report receiving medical intervention and was hospitalized for seven days.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

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 reported an allegation of an issue related to a cpap device's sound abatement foam.The manufacturer received information alleged caused a stroke and numbness on the right side.The patient did report receiving medical intervention and was hospitalized for seven days.The device was returned to the manufacturer's service center for further evaluation.  the device was evaluated.There was no mention of visual findings to the external part of the device.  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 there was no visible foam degradation and unit passed the final test.Section d4 (unique identifier (udi) #) captured incorrectly in previous report.It has been corrected in this report.Section h6 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: 13078349
• MDR Text Key: 282719146
• Report Number: 2518422-2021-08491
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500T12C
• Device Catalogue Number: CAX500T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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; Other