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

Model Number DSX500T11C

Device Problems Smoking (1585); Sparking (2595); Insufficient Information (3190)

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

Event Date 12/28/2020

Event Type  malfunction  

Event Description

The manufacturer became aware of an allegation of a thermal event occurring to the dc power inlet port on a continuous positive airway pressure (cpap) device.There was no patient harm or injury reported.The manufacturer requested the return of the device with power accessories for evaluation.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer previously reported a thermal event occurred to the dc power inlet port on a continuous positive airway pressure (cpap) device.There was no patient harm or injury reported.Additional information received indicated allegations of only sparking and smoking was seen at the dc power inlet port and some damage to the dc power supply.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR),
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11314785
• MDR Text Key: 231403480
• Report Number: 2518422-2021-00327
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959025646
• UDI-Public: 00606959025646
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DREAMSTATION HUMIDIFIER S/N (B)(4).; DREAMSTATION HUMIDIFIER- S/N (B)(4); DREAMSTATION HUMIDIFIER- S/N (B)(4)
• Patient Outcome(s): Death
• Patient Age: 58 YR