MAUDE Adverse Event Report: RESPIRONICS,INC. SYSTEM ONE HEATED HUMIDIFIER; VENTILATOR, NON-CONTINIOUS (RESPIRATOR), PRODUCT CODE BZD

Model Number DS6HFLG

Device Problem Device Operational Issue (2914)

Patient Problem Tooth Fracture (2428)

Event Date 11/06/2017

Event Type  Injury  

Event Description

An end user alleges developing tooth decay and a need for tooth implants due to inadequate humidification while using a heated humidifier and associated continuous positive airway pressure (cpap) device.The user reportedly has dentures at this time.The manufacturer has made multiple requests for the return of these devices for evaluation, and for additional information.To date, no product has returned, and no further information has been provided.The durable medical equipment (dme) supplier indicated to the manufacturer that the heated humidifier and cpap devices were working properly.The system one heated humidifier is an accessory for therapy devices to provide moisture to the patient circuit.It is intended for use in spontaneously breathing patients weighing over 30 kg (66 lbs.), 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 and 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.Do not use the humidifier if the water tank is leaking or damaged in any way.Have any damaged parts replaced before continuing use." the absence of heated, humidified air does not represent a serious risk of permanent harm or injury.Based on the information available, the manufacturer is unable to confirm the allegation the end user developed tooth decay as a result of inadequate humidification.The manufacturer concludes that no further action is necessary at this time.If additional information is provided, or if the devices are received for investigation, the manufacturer will file a supplemental report.

• Brand Name: SYSTEM ONE HEATED HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINIOUS (RESPIRATOR), PRODUCT CODE BZD
• 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: 7109682
• MDR Text Key: 94620218
• Report Number: 2518422-2017-02850
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS6HFLG
• Device Catalogue Number: DS6HFLG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 72 YR