V SERIES MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-21 for V SERIES MONITOR manufactured by Mindray Ds Usa Inc.

Event Text Entries

[17696832] Customer reported v series monitor came off vdock and fell. This took place shortly after the monitor had been moved from one vdock to another. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5

[17781753] The customer also requested training on proper docking at the time. Mindray service rep evaluated monitor and dock on site and found no visible evidence of defect in dock latching mechanisms. Device is being shipped to mindray national repair ctr for further eval.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2221819-2014-00503
• MDR Report Key: 4037792
• Report Source: 05,06,07
• Date Received: 2014-08-21
• Date of Report: 2014-07-18
• Date Mfgr Received: 2014-07-18
• Date Added to Maude: 2014-09-05
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: WISARA SETHACHUTKUL
• Manufacturer Street: 800 MACARTHUR BLVD.
• Manufacturer City: MAHWAH NJ 07430
• Manufacturer Country: US
• Manufacturer Postal: 07430
• Manufacturer Phone: 2019558045
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: V SERIES MONITOR
• Generic Name: PATIENT MONITOR
• Product Code: BZK
• Date Received: 2014-08-21
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MINDRAY DS USA INC
• Manufacturer Address: MAHWAH NJ US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-08-21