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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500 Back to Search Results
Catalog Number 10492730
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2015
Event Type  No Answer Provided  
Event Description
Customer restored failed automatic quality control (level 1&3) parameters (ph, na+, cl-, ca++ and pco2) and run patient sample.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer indicated that they will retrain the perfusionist who restored the automatic quality control (aqc) and they will run all aqc levels three times a day.Siemens technical solution center team reviewed the option of setting security levels with customer to prevent restoring aqc.The event has occurred due to an operator error.
 
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Brand Name
RAPIDPOINT 500
Type of Device
RP 500
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industry
sudbury CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key4812180
MDR Text Key17536211
Report Number1217157-2015-00066
Device Sequence Number1
Product Code KQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2015
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 Other Health Care Professional
Device Catalogue Number10492730
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2015
Initial Date FDA Received06/02/2015
Is the Device Single Use? No
Patient Sequence Number1
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