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

Model Number AHX500H11

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Nausea (1970); Taste Disorder (4422); Unspecified Respiratory Problem (4464); Unspecified Eye / Vision Problem (4471)

Event Date 08/27/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged nausea, eye issue, nose issue, unable to smell and taste.There was no report serious or permanent of 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 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 patient alleged nausea, eye issue, nose issue, unable to smell and taste.There was no report of serious or permanent harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.The device was evaluated.As per the investigation of the device evidence of sound abatement foam degradation/breakdown was not observed in the base unit and device provided airflow during therapy.As per secondary findings of the base unit observed minor dust/dirt contamination on top and bottom enclosures, sd cover flip door, ui panel, blower box, blower, blower outlet seal, and rear panel.Unknown contaminate on accessory module flip door, inside rear panel, inside top enclosure, inside ui panel, and control dial.Blower outlet seal not seated correctly but will not affect airflow.A contaminate consistent with keratin was observed on the blower box.The device's downloaded event log was reviewed by the manufacturer and found 1 error.The manufacturer concludes unable to address the symptoms described and confirm the presence of contamination in the airpath.

• 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: 15111909
• MDR Text Key: 296695496
• Report Number: 2518422-2022-65410
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022560
• UDI-Public: 00606959022560
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AHX500H11
• Device Catalogue Number: AHX500H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2015
• 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