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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 Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2015
Event Type  No Answer Provided  
Event Description
Customer ran 3 patient samples when automatic quality control (aqc) was turned off for 8 hours.There was no report of injury due to this event.
 
Manufacturer Narrative
Customer should not have run patient samples when aqc turned off on the instrument.The customer had level 2 security access for their employees.Siemens representative provided security information on all 3 aqc levels to prevent the recurrence of this event.Customer confirmed that there was no negative impact on patient treatment due to this event.All 3 aqc levels were in range when aqc was turned back on.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 Key4871174
MDR Text Key5860245
Report Number1217157-2015-00085
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 05/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2015
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
Date Manufacturer Received05/31/2015
Is the Device Single Use? No
Patient Sequence Number1
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