MAUDE Adverse Event Report: DRAEGER ; INFINITY ACUTE CARE SYSTEM

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Type  malfunction  

Event Description

During routine audit, arrhythmia alarms found to be "off." it was verified that staff did not initiate this change in alarm status.

• Type of Device: INFINITY ACUTE CARE SYSTEM
• Manufacturer (Section D): DRAEGER ; telford PA 18969
• MDR Report Key: 5267632
• MDR Text Key: 32756142
• Report Number: MW5058315
• Device Sequence Number: 1
• Product Code: MHX
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR