MAUDE Adverse Event Report: DRAEGER INFINITY ACUTE CASE SYSTEM; INFINITY ACUTE CARE SYSTEM

Device Problem No Display/Image (1183)

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

Event Date 10/22/2015

Event Type  malfunction  

Event Description

During arrhythmia alarm check on iacs, it was noted that there was a blank screen in the "alarm" menu.The vital sign parameters and arrhythmia setting screens were blank and frozen.The arrhythmia profile was basic and promptly changed to advanced.Unable to print screen.Ics central station frozen/greyed out showing the arrhythmia profile of basic, despite advanced in the room.

• Brand Name: INFINITY ACUTE CASE SYSTEM
• Type of Device: INFINITY ACUTE CARE SYSTEM
• Manufacturer (Section D): DRAEGER; telford PA 18969
• MDR Report Key: 5267555
• MDR Text Key: 32753066
• Report Number: MW5058298
• Device Sequence Number: 1
• Product Code: DSK
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR