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

Model Number AUG500S15

Device Problem Flare or Flash (2942)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2020

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation that a user awoke to a burning, plastic odor and a thermal event occurring to the continuous positive airway pressure (cpap) device.The user reported there was a small flame or flash.It was not indicated where the damage occurred.There was no patient harm or injury.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

(date of this report) and (date received by manufacturer) on the initial report should be 03/26/2020.This is our awareness date.

Manufacturer Narrative

The device and humidifier were returned to the manufacturer and the customer's complaint was confirmed that a thermal failure to the humidifier pca had occurred.The root cause was determined to be water ingress to the humidifier pca board , heat plate and to the base unit blower motor and box.The philips respironics dreamstation go 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.Product labeling states "when installing the water tank, do not allow any water to spill into the humidifier or therapy device.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 supplier." these devices meet ul and iec requirements for flammability.There was no patient harm or injury.Based on the available information, the manufacturer concludes this is an isolated incident and no further action is necessary.The manufacturer will continue to monitor for trends.

Manufacturer Narrative

For the initial report, the date of awareness should be 03/26/2020, so date of this report on the initial should be 03-26-2020, same as the date of the event.

• Brand Name: DREAMSTATION GO AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 9982374
• MDR Text Key: 188388986
• Report Number: 2518422-2020-00832
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959044470
• UDI-Public: 00606959044470
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AUG500S15
• Device Catalogue Number: AUG500S15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER (B)(4).; MASK.; HUMIDIFIER (B)(4); MASK
• Patient Age: 48 YR