MAUDE Adverse Event Report: GE HEALTHCARE GE ENGSTROM CARESTATION; CARESTATION VENTILATOR

Model Number 1505-9000-000

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Apnea (1720)

Event Date 01/04/2014

Event Type  No Answer Provided  

Event Description

Ventilator stopped working while on pt, screen blacked out with lines running through it and "apnea" on the screen.Clinical engineer later tested the ventilator.It operated properly and the problem was not replicated.Available event, alarm, and key press logs were downloaded.There is no interruption in logs at the time of the noted failure.Machine was turned off after event so trend logs were reset and are empty.

• Brand Name: GE ENGSTROM CARESTATION
• Type of Device: CARESTATION VENTILATOR
• Manufacturer (Section D): GE HEALTHCARE; 3030 ohmeda dr; madison WI 53718
• MDR Report Key: 3580923
• MDR Text Key: 20267738
• Report Number: MW5033885
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2014

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: Health Professional
• Device Model Number: 1505-9000-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELEFLEX NEPTUNE MODEL 425-00 HUMIDIFIER
• Patient Outcome(s): Life Threatening; Required Intervention