FDA.reportPublic FDA data

MAUDE MDR 7576120

MDR report key
7576120
Report number
3009156722-2018-00005
Event key
0
Event type
3
Date of event
2018-03-23
Date received
2018-06-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. SERENA CHEN
Address
KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK SHENZHEN, NANSHAN 51805 CH
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BENEVISION CENTRAL MONITORING SYSTEMBENEVISIONSHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTDMSXBENEVISION CENTRAL MONITORING SYSTEMR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-060

Event Narratives#

N

Patient 1

MINDRAY FIELD SERVICE REPRESENTATIVE VISITED THE SITE AND COLLECTED ERROR LOST FROM MULTIPLE SYSTEMS. AN EVALUATION IS UNDERWAY, HOWEVER, IT IS NOTED THAT THE SITE WAS UNABLE TO PROVIDE SPECIFIC INFORMATION ABOUT THE TIME OF THE EVENT, THE SYSTEM INVOLVED OR OTHER EVIDENCE OF THE EVENT SUCH AS ECG STRIPS. (B)(4).

D

Patient 1

THE CUSTOMER REPORTED THAT CENTRAL MONITOR SYSTEM FAILED TO ALARM WHEN A PATIENT EXPERIENCED A RUN OF VENTRICULAR RHYTHM. SOURCE OF THE REPORT: MW5076872. NO PATIENT INJURY WAS REPORTED.