MAUDE Adverse Event Report: RESPIRONICS,INC. REMSTAR SE ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR),

Model Number	220P
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user alleges she developed receding gums due to inadequate humidification while using a continuous positive airway pressure (cpap) device and associated humidifier.The user reported undergoing surgery to correct her receding gums.The patient discontinued therapy approximately four months prior to the completion of the dental procedure.The manufacturer received the cpap and heated humidifier for evaluation and could not confirm the user's allegation.There were no operational or humidification issues with the devices.Both units passing all testing and functioned as designed.The durable medical equipment (dme) provider states the patient had very poor compliance and overall poor tolerance of the cpap therapy while using the device between (b)(6) 2017.A review of the data indicates there was humidification during all therapy sessions.The 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 (b)(6) kg ((b)(6) 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 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.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 concludes the devices have functioned as designed and no further action is necessary.

• Brand Name: REMSTAR SE ASSY
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR),
• Manufacturer (Section D): RESPIRONICS,INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 6972679
• Report Number: 2518422-2017-02343
• Device Sequence Number: 1118334
• Product Code: BZD
• UDI-Device Identifier: 00606959038356
• UDI-Public: 00606959038356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 220P
• Device Catalogue Number: 220P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEATED HUMIDIFIER , SN: (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR