MAUDE Adverse Event Report: DRAEGER DRAEGER; BP MONITOR INFINITY M540

Model Number INFINITY M540

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/12/2016

Event Type  malfunction  

Event Description

Bp monitor not working.Unable to get readings.Bp module was exchanged.Same serial number and module as reported on (b)(6) 2016.

• Brand Name: DRAEGER
• Type of Device: BP MONITOR INFINITY M540
• Manufacturer (Section D): DRAEGER; telford PA 18969
• MDR Report Key: 5856059
• MDR Text Key: 51732279
• Report Number: MW5063907
• Device Sequence Number: 1
• Product Code: MSX
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFINITY M540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR