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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Hemoptysis (1887); Unspecified Respiratory Problem (4464); Dry Mouth (4485)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

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 received information alleging headaches; dry nose, mouth, and throat.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously receiving information alleging headaches, dry nose, mouth, and throat an issue related to a cpap device's sound abatement foam.The manufacturer also received information alleging headaches and coughing up blood.Section b3, g3 was reported incorrectly in previous report which is now been corrected in this follow-up report.Section h6 has been updated in this follow-up report.

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 received information alleging headaches; dry nose, mouth and throat related to cpap device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.The internal and external aspect of the device was inspected and the manufacturer observed presence of dust/dirt contamination on the blower box, outlet iso port and on the air inlet of the motor was inconsistent with degraded sound abatement foam contamination.The presence of contamination within the airpath, suggests a source external to the device.The evidence of water ingress was found by the manufacturer on the bottom of the blower box and on the bottom of the motor.The device's event logs were downloaded and reviewed by the manufacturer.The manufacturer found no error codes.The manufacturer concludes there was no evidence of sound abatement foam degradation, but water ingress and dust contamination was observed and are consistent with being from an external source.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 15421126
• MDR Text Key: 302926172
• Report Number: 2518422-2022-78989
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2021
• Initial Date FDA Received: 09/14/2022
• Supplement Dates Manufacturer Received: 09/12/2022; 07/13/2023
• Supplement Dates FDA Received: 09/24/2022; 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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