MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD,, PRODUCT CODE: BZD

Model Number DSX700H11C

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Bronchitis (1752); Pneumonia (2011); Patient Problem/Medical Problem (2688)

Event Date 11/26/2018

Event Type  Injury  

Event Description

The manufacturer was made aware that a bilevel positive airway pressure (bipap) device used in conjunction with a heated humidifier allegedly caused a user to develop bronchitis and pneumonia due to the water spilled into her machine when overfilling her water chamber.The user reportedly was hospitalized for three days with pneumonia and sepsis.There is no information as to the treatment received in the hospital.The manufacturer's investigation is on-going.The devices have been requested and have yet to be received by the manufacturer.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the devices for investigation.There was no evidence of a failure of the received devices that would have caused or contributed to the reported event.There were no contaminants found within the dreamstation bipap.The pollen filter and the ultra-fine filter were slightly discolored and the humidifier water chamber had some evidence of contamination likely as a result of tap water being used.The devices performed as intended and passed all testing.There were no operational issues found.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over (b)(6) kg ((b )(6) lbs).It is for use in the home or hospital/institutional environment.If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, or if the enclosure is broken, disconnect the power cord from the therapy device and discontinue use.Contact your home care provider.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur." the device uses a blue pollen filter that is washable and reusable, and a light-blue ultra-fine filter that is disposable.The reusable blue filter screens out normal household dust and pollens, while the light-blue ultra-fine filter provides more complete filtration of very fine particles.The reusable blue filter must be in place at all times when the device is operating.The ultra-fine filter is recommended for people who are sensitive to tobacco smoke or other small particles.This device has an automatic air filter reminder.Every 30 days, the device will display a message reminding you to check your filters and replace them as directed.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) kg ((b )(6) lbs), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.The user manual cautions users 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.Before cleaning the humidifier, always remove from the therapy device.Empty and clean the water tank daily to prevent mold and bacteria growth.Use a mild liquid dishwashing detergent only for either hand washing or when using a dishwasher".Based on the available information, the manufacturer concludes that no further action is necessary at this time.

• Brand Name: DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR), PRODUCT CODE:BZD,, 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 kensington, PA 15068 ; 7243349303
• MDR Report Key: 8135328
• MDR Text Key: 129432391
• Report Number: 2518422-2018-02932
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025691
• UDI-Public: 00606959025691
• 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
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

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: DSX700H11C
• Device Catalogue Number: DSX700H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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
• Patient Outcome(s): Hospitalization