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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION

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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION Back to Search Results
Model Number 0998-00-0710-01
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2015
Event Type  Malfunction  
Manufacturer Narrative

This is a resubmission of the original mdr (submitted via paper copy on (b)(6) 2015) made at the request of the fda who notified the company they cannot locate the original mdr.

 
Event Description

Customer reported the panorama central station with telemetry had lost communication, which may have affected telemetry monitoring. No patient injury was reported.

 
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Brand NamePANORAMA CENTRAL STATION WITH TELEMETRY
Type of DeviceCENTRAL MONITORING STATION
Manufacturer (Section D)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
1203 nanhuan avenue
guangming district
shenzhen, shenzhen 51810 6
CH 518106
Manufacturer (Section G)
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
1203 nanhuan avenue
guangming district
shenzhen, guandong 51810 6
CH 518106
Manufacturer Contact
patrice martinez
800 macarthur blvd
mahwah, NJ 07430
2019958026
MDR Report Key11510063
MDR Text Key267517286
Report Number3009156722-2015-00261
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/16/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number0998-00-0710-01
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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