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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 Back to Search Results
Catalog Number 10492730
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2013
Event Type  Other  
Event Description
Customer reported that automatic qc(aqc) was turned off on the instrument from (b)(6) 2013 at 06:09am to (b)(6) 2013 at 11:30am.Customer indicated that pt samples were run during that time frame.There was no report of injury due to this event.
 
Manufacturer Narrative
The event has occurred due to an operator error.Operator should not have run pt samples when the automatic qc(aqc) was off on the instrument.Customer indicated that they turned on the automatic qc(aqc) on the instrument on (b)(6) 2013.Instrument is operational.
 
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Brand Name
RAPIDPOINT 500
Type of Device
RAPIDPOINT 500
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steve andberg
2 edgewater dr.
norwood, MA 02062
7812693655
MDR Report Key3581671
MDR Text Key20010866
Report Number1217157-2013-00245
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 12/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2014
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
Date Manufacturer Received12/11/2013
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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