MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATORY, NON-CONTINUOUS (RESPIRATOR)

Model Number CAX500T12

Device Problems Pressure Problem (3012); Noise, Audible (3273)

Patient Problem Atrial Fibrillation (1729)

Event Date 03/09/2020

Event Type  Injury  

Event Description

The manufacturer became aware that a user alleges while using a continuous positive airway pressure (cpap) device , the user stated the dreamstation auto cpap was very loud and had felt it was not delivering the correct pressure.The user was unable to sleep and started having chest pains.The user went to the emergency room and had to be cardioverted to regulate his atrial fibrillation.The user has a pre-existing medical history of atrial fibrillation.Patient was discharged home the next day.There was no serious or permanent injury.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 auto cpap and associated humidifier for investigation.The investigation confirms the noise complaint.There was presence of dark contaminants and water ingress to the blower assembly resulting in degradation of the blower bearings leading to the noise complaint.The finding of water ingress to the dreamstation assembly indicates the units were moved or mishandled while there was still water in the chamber of the associated humidifier.There was also more evidence of dark contaminants present at the air inlet filter and throughout both devices.The investigation found no evidence of the pressures fluctuating outside of the pre-set therapy pressure levels.The patient encore reports indicates the pressure levels did vary due to a response of the device from the patient breathing events as designed for auto therapy.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 and discontinue use.Contact your home care provider.There was no serious patient harm or injury.The manufacturer concludes that no further action is necessary at this time.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATORY, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 9825187
• MDR Text Key: 183151555
• Report Number: 2518422-2020-00648
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959026605
• UDI-Public: 00606959026605
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX500T12
• Device Catalogue Number: CAX500T12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER S/N (B)(4).
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR