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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500
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SIMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500 Back to Search Results
Catalog Number 10492730
Device Problem Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2014
Event Type  Other  
Event Description
Customer reported that not all levels of po2 automatic quality control were run on instrument between 2:00am - 10:00am on (b)(6) 2014 and 4 patient samples were run during this time.Customer indicated that all the aqc's were run for po2 at 10:00 am and they passed.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 patient samples during the time when qc was not run.Instrument is performing as intended.
 
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Brand Name
RAPIDPOINT 500
Type of Device
RP 500
Manufacturer (Section D)
SIMENS HEALTHCARE DIAGNOSTICS
511 benedict ave.
tarrytown NY 10591
Manufacturer (Section G)
SIMENS HEALTHCARE DIAGNOSTICS, MANUFACTURING, LTD.
northern rd.
sudbury, suffolk CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steve andberg
2 edgewater dr.
norwood, MA 02062
7812693655
MDR Report Key3628075
MDR Text Key4178806
Report Number1217157-2014-00010
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 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2014
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 Received01/13/2014
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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