MAUDE Adverse Event Report: DRAEGER INFINITY ACUTE CARE SYSTEM

Device Problem No Display/Image (1183)

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

Event Date 10/01/2015

Event Type  malfunction  

Event Description

Ecg with intermittent display on iacs, and disappearing on ics.Turned m540 off and back on, with ecg reappearing.Full disclosure lost during time period immediately prior to that hour.

• Brand Name: INFINITY ACUTE CARE SYSTEM
• Type of Device: INFINITY ACUTE CARE SYSTEM
• Manufacturer (Section D): DRAEGER; telford PA 18969
• MDR Report Key: 5267560
• MDR Text Key: 32754090
• Report Number: MW5058299
• 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 an Adverse Event Report?: No
• 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: 50 YR