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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 Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued.The customer has changed the measurement cartridge.Siemens has requested the r1 files for investigation.Siemens service went on site and the service report is pending.The root cause for the discrepant results is unknown.
 
Event Description
The customer reported discrepant total hemoglobin results on two patients between two rp 500 analyzers.There was no report of injury due to this event.
 
Manufacturer Narrative
Changed "date of event" to (b)(6) 2018.Manufacturer narrative: the customer stated that the r1 files are not available.Siemens reviewed the event log and there are no persistent sensor errors or system errors for this cartridge.Siemens service went onsite and changed the connector block and then replaced the cartridge interface frame (cif).The system is operational.
 
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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
MDR Report Key8161304
MDR Text Key131010809
Report Number3002637618-2018-00134
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K122539
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number10697306
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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