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

Model Number DSX700S11F

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of a thermal event on a dreamstation auto bipap.When the user turned on his machine, he reported seeing a flame and smoke at the power input port on the device.The user also reported burn marks at the power inlet, on the dc power supply, and on the power supply cord.There was no report of patient harm or injury.The device with power accessories has not yet been returned for investigation.The investigation is on-going.A follow up final will be submitted once the investigation is complete.

Manufacturer Narrative

The manufacturer received the devastation auto bipap with power accessories for evaluation.There was evidence of an external spill on the power supply and cables, showing mineral deposits, corrosion and minor thermal damage to the dc input cable.Since there was no evidence of water ingress internally to the device, this suggests the source of the spill was external to the device.There was corrosion/oxidation due to liquid ingress at the power input on the device.There was no evidence of fire or thermal damage internal to the device.The device does power up and provides flow.The manufacturer concludes no further action is necessary.There was no patient harm or injury reported.

• Brand Name: DREAMSTATION AUTO BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13632954
• MDR Text Key: 286322897
• Report Number: 2518422-2022-05575
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700S11F
• Device Catalogue Number: DSX700S11F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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 Age: 89 YR
• Patient Sex: Male