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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500 Back to Search Results
Catalog Number 10697306
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/17/2017
Event Type  malfunction  
Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results and corrected reports were issued.The cause for this event is unknown.
 
Event Description
The customer reported discordant sodium values on an rp 500 compared to another laboratory instrument.There was no reported injury due to this event.
 
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Brand Name
RAPIDPOINT 500 BLOOD GAS ANALYZER
Type of Device
RP 500
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
northern road
chilton industrial estate
sudbury, CO10 2XQ
UK   CO10 2XQ
Manufacturer Contact
steven andberg
2 edgewater drive
norwood, MA 02062
7812693655
MDR Report Key6439504
MDR Text Key71276129
Report Number3002637618-2017-00054
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K113216
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number10697306
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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