• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINDRAY DS USA, INC. PANORAMA CENTRAL STATION NONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MINDRAY DS USA, INC. PANORAMA CENTRAL STATION NONE Back to Search Results
Device Problems Electrical /Electronic Property Problem (1198); Device Stops Intermittently (1599)
Patient Problem Death (1802)
Event Date 06/30/2012
Event Type  Death  
Event Description

The customer reported that a pt expired during the time that the panorama central station shut down on (b)(6) 2012. The customer reported that the pt's death was not attributed to the loss of monitoring by the panorama central station.

 
Manufacturer Narrative

The customer could not confirm whether the pt was being monitored by a bedside monitor or an ambulatory telepack at the time of the reported shut down. Further, the customer did not attribute the pt's death to the reported loss of monitoring at the panorama central station. A mindray service representative evaluated the panorama central station and was informed by the customer that prior electrical safety maintenance check-ups were performed by a third party biomedical company; rather than mindray service.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePANORAMA CENTRAL STATION
Type of DeviceNONE
Manufacturer (Section D)
MINDRAY DS USA, INC.
mahwah NJ
Manufacturer Contact
wisara sethachutkul
800 macarthur blvd
mahwah, NJ 07430
MDR Report Key2773454
MDR Text Key21263182
Report Number2221819-2012-00002
Device Sequence Number1
Product Code MHX
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Remedial Action Repair
Type of Report Initial
Report Date 09/30/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/26/2012 Patient Sequence Number: 1
-
-