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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY BIO-MEDICAL ELECTRONICS CO LTD PANORAMA CENTRAL STATOIN WITH TELEMETRY; CENTRAL MONITORING STATION
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MINDRAY BIO-MEDICAL ELECTRONICS CO LTD PANORAMA CENTRAL STATOIN WITH TELEMETRY; CENTRAL MONITORING STATION Back to Search Results
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2014
Event Type  malfunction  
Event Description
Customer reported an issue with the panorama central station's display, which may have affected telemetry monitoring.No pt injury was reported.
 
Manufacturer Narrative
Company rep evaluated the unit.Corrections included replacement of the unit's lcd module and inverter board.Unit was safety tested to factory's specifications.
 
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Brand Name
PANORAMA CENTRAL STATOIN WITH TELEMETRY
Type of Device
CENTRAL MONITORING STATION
Manufacturer (Section D)
MINDRAY BIO-MEDICAL ELECTRONICS CO LTD
shenzhen
CH 
Manufacturer (Section G)
MINDRAY BIO-MED ELECTRONICS CO LTD
keji 12th rd s, industrial park
nanshan, shenzhen 5180 57
CH   518057
Manufacturer Contact
wisara sethachutkul
800 macarthur blvd.
mahwah, NJ 07430-0619
2019958045
MDR Report Key4479760
MDR Text Key19765290
Report Number2221819-2014-01046
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K1420601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/08/2014,11/11/2014
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/11/2014
Event Location Hospital
Initial Date Manufacturer Received 11/11/2014
Initial Date FDA Received01/12/2015
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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