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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 Problems Loss of Data (2903); Patient Data Problem (3197)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/19/2014
Event Type  malfunction  
Event Description
Customer reported that a patient sample result was missing from patient list on the instrument and it was not transferred to data management system (lis).There was no report of injury or treatment being delayed due to this event.
 
Manufacturer Narrative
Siemens field service engineer (fse) went into the patient list to recall the patient result and it was blank and he did not get a print out because the printer was turned off.Siemens fse replaced hard drive and cable along with main board due to scorched hard drive and restored set up.Instrument hard drive was replaced and not retained therefore no log files could be reviewed for investigation.System is operational.
 
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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 Key4309691
MDR Text Key19970932
Report Number1217157-2014-00187
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 11/20/2014
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 Other Health Care Professional
Device Catalogue Number10492730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2014
Initial Date FDA Received12/09/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Patient Sequence Number1
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