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

Model Number CAX500T12

Device Problem Degraded (1153)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Rash (2033)

Event Date 02/09/2023

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 an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing conjunctivitis, dry eyes, congestion and skin rashes.There was no report of serious patient harm or injury.The patient.Has reported to have been using eye drops and skin creams.The manufacturers investigation is ongoing.A follow-up report will be submitted when the manufacturers investigation is complete.

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 an issue related to a cpap device's 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, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing conjunctivitis, dry eyes, congestion, sore upper lips and skin rashes.There was no report of serious patient harm or injury.The patient has reported to have seen a dermatologist and has been using eye drops and skin creams.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Section h.

• 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 15208 ; 4125423300
• MDR Report Key: 16567218
• MDR Text Key: 311588097
• Report Number: 2518422-2023-07171
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500T12
• Device Catalogue Number: CAX500T12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1