MAUDE Adverse Event Report: RESPIRONICS,INC. DREAMSTATION HUMIDIFIER; VENTILATOR, NON-CONTINIOUS (RESPIRATOR)

Model Number DSXHCP

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Complaint, Ill-Defined (2331); Difficulty Chewing (2670)

Event Date 12/05/2017

Event Type  Injury  

Event Description

An end user alleges developing bridge loss due to inadequate humidification while using a heated humidifier and associated continuous positive airway pressure (cpap) device.The durable medical equipment (dme) supplier evaluated the devices and they were working properly.The manufacturer has requested the return of the devices for investigation.Upon conclusion of the manufacturer's investigation a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the devices for evaluation and was unable to confirm the patient's complaint.There were no operational issues and the devices passed all testing and functioned as designed.The dreamstation heated humidifier is an accessory for the philips respironics dreamstation therapy devices to provide moisture to the patient circuit.It is intended for use in spontaneously breathing patients weighing over (b)(6), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.Labeling instructs the user to "periodically inspect the humidifier for signs of wear or damage.Never operate the humidifier if any parts are damaged, if it is not working properly, or if the humidifier has been dropped or mishandled." when the heated humidifier is not heating, it acts as a passover humidifier which adds moisture at room temperature to the therapy device's airflow.The loss of heated humidification for the intended patient population does not pose a significant health or safety risk.The manufacturer concludes no further action is required.

• Brand Name: DREAMSTATION HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINIOUS (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: adam price ; 312 alvin drive; new kensingtom, PA 15068 ; 7243349303
• MDR Report Key: 7128688
• MDR Text Key: 95213368
• Report Number: 2518422-2017-02925
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959022652
• UDI-Public: 00606959022652
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSXHCP
• Device Catalogue Number: DSXHCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DREAMSTATION AUTO CPAP, SN (B)(4)
• Patient Outcome(s): Other
• Patient Age: 69 YR