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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS RAPIDPOINT 500
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SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS RAPIDPOINT 500 Back to Search Results
Catalog Number 10492730
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2013
Event Type  Other  
Event Description
Customer indicated that automatic quality control (aqc) was not run on the instrument from (b)(6) 2013.Customer indicated that 15 pt samples were run during this time frame.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer is being instructed to set up automatic quality control (aqc) on the instrument.Custom should not have run pt samples when aqc was off on the instrument.The event has occurred due to an operator error.Instrument is performing as intended.
 
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Brand Name
RAPIDPOINT 500
Type of Device
RAPIDPOINT 500
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
northern rd
sudburgy, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steve andberg
2 edgewater dr.
norwood, MA 02062
7812693655
MDR Report Key3608253
MDR Text Key4171781
Report Number1217157-2013-00262
Device Sequence Number1
Product Code KHP
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/26/2013
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 Health Professional
Device Catalogue Number10492730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/26/2013
Initial Date FDA Received01/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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