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

Model Number DSX500H11C

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Respiratory Distress (2045); Respiratory Tract Infection (2420); Choking (2464)

Event Date 06/02/2018

Event Type  Injury  

Event Description

The manufacturer was made aware that a continuous positive airway pressure (cpap) device used in conjunction with a heated humidifier allegedly caused a user with existing sinus and allergy issues to experience difficulty breathing.The user reportedly went to the hospital and was diagnosed with atrial fibrillation.There is no information as to treatment of the condition or duration of admission at this time.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the cpap and associated humidifier for investigation.There were no operational issues noted and the devices functioned as designed.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs).It is for use in the home or hospital/institutional environment.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.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, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord the philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of and discontinue use.Contact your home care provider." based on the information available, the manufacturer is unable to confirm the complaint.No further action is necessary.

Manufacturer Narrative

The manufacturer received the cpap and associated humidifier for investigation.There were no operational issues noted and the devices functioned as designed.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over 30 kg (66 lbs).It is for use in the home or hospital/institutional environment.The user is cautioned "contact your health care professional if symptoms of sleep apnea recur.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, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord the philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of and discontinue use.Contact your home care provider." based on the information available, the manufacturer is unable to confirm the complaint.No further action is necessary.Corrected data: this was erroneously reported as mdr 2518422-2018-01421-1.

Manufacturer Narrative

Additional information was received and section b5 should be reported as: the manufacturer was made aware that a continuous positive airway pressure (cpap) device used in conjunction with a heated humidifier allegedly caused a user with existing sinus and allergy issues to experience difficulty breathing.The user reportedly went to the hospital and was diagnosed with atrial fibrillation.There is no information as to treatment of the condition or duration of admission at this time.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected externally observed that evidence of contaminants present in the inlet filters & the internal surface of the chamber is coated with an unknown contaminant.The manufacturer operated the devices at the received settings found no indication of a failure.The investigation performed by product investigation laboratory found no evidence of a failure with the dreamstation auto, sd card, dc power supply, ac power cord, or humidifier that would have resulted in the reported events.The manufacturer concludes there was no evidence of a failure and logged error codes.The manufacture observed that evidence of contaminants present in the inlet filters & the internal surface of the chamber.Section h6 type of investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (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 kensington, PA 15068 ; 2673970028
• MDR Report Key: 7621684
• MDR Text Key: 111756237
• Report Number: 2518422-2018-01431
• 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: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

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: DSX500H11C
• Device Catalogue Number: DSX500H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 08/16/2018; 08/16/2018
• Supplement Dates FDA Received: 08/08/2023; 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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 HUMIDIFIER S/N(B)(4) ; DREAMSTATION HUMIDIFIER S/N(B)(4)
• Patient Outcome(s): Hospitalization
• Patient Sex: Male