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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY DS USA, INC. PANORAMA CENTRAL STATION WITH TELEMETRY; CENTRAL MONITORING STATION
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MINDRAY DS USA, INC. PANORAMA CENTRAL STATION WITH TELEMETRY; CENTRAL MONITORING STATION Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2014
Event Type  malfunction  
Event Description
Customer reported an issue with the panorama central station, which may have affected telemetry monitoring.No patient injury was reported.
 
Manufacturer Narrative
Company representative evaluated the system and found the antennas had no power.Corrections including clearing the system's error logs and rebooting the power to the system server.System was safety tested to factory's specifications.Issue may be the result of a problem with the site's back up generator.
 
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Brand Name
PANORAMA CENTRAL STATION WITH TELEMETRY
Type of Device
CENTRAL MONITORING STATION
Manufacturer (Section D)
MINDRAY DS USA, INC.
mahwah NJ
Manufacturer Contact
wisara sethachutkul
800 macarthur blvd.
mahwah, NJ 07430
2019958045
MDR Report Key4037876
MDR Text Key4726564
Report Number2221819-2014-00457
Device Sequence Number1
Product Code BZK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
031760
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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