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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500

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SIEMENS HEALTHCARE DIAGNOSTICS INC. RAPIDPOINT 500 BLOOD GAS ANALYZER; RP 500 Back to Search Results
Model Number 10492730
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2022
Event Type  malfunction  
Manufacturer Narrative
Siemens requested instrument log files to perform further investigation.The customer was unable to provide these files therefore investigation cannot be performed.The cause of this event is unknown.
 
Event Description
The customer reported a discrepant lactate result compared to retesting of a different sample on a non-siemens lab instrument.There is no report of 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 INC.
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
thomas myers
511 benedict avenue
tarrytown, NY 10591
MDR Report Key16240080
MDR Text Key308769396
Report Number3002637618-2023-00002
Device Sequence Number1
Product Code CHL
UDI-Device Identifier00630414589169
UDI-Public00630414589169
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122539
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 01/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10492730
Device Catalogue Number10492730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2023
Initial Date FDA Received01/25/2023
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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