MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO SV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DEX900S13

Device Problem Failure to Power Up (1476)

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

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : sent to a third-party service center.

Event Description

A device was returned to a third-party repair center for service.The device was not in patient use.During the service evaluation of the device, the third-party repair center visually inspected the device and found corrosion on the power supply connectors.The device was not able to power up.There was no report of patient or user harm or injury.The manufacturer is submitting a final report at this time.

• Brand Name: DREAMSTATION AUTO SV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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 15208 ; 4125423300
• MDR Report Key: 17970922
• MDR Text Key: 326248272
• Report Number: 2518422-2023-27377
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: DEX900S13
• Device Catalogue Number: DEX900S13
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1