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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 Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2013
Event Type  Other  
Event Description
Customer reported that they restored the thb parameter on the instrument after the quality control failed and disabled the parameter on the instrument.The customer reported running patient samples prior to confirming that the quality control results for thb were within range.There was no report of injury due to this event.
 
Manufacturer Narrative
The event has occurred due to an operator error.Customer should not have run pt samples with the restored parameter (thb), until the quality control results were confirmed to be acceptable.Instrument is performing as intended.
 
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Brand Name
RAPIDPOINT 500
Type of Device
RAPIDPOINT 500
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
terrytown 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
7912693655
MDR Report Key3608297
MDR Text Key4172786
Report Number1217157-2014-00001
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 01/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2014
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 Received01/02/2014
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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