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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 405 BLOOD GAS ANALYZER; RP 405
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SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 405 BLOOD GAS ANALYZER; RP 405 Back to Search Results
Catalog Number 10322347
Device Problems Application Security Problem (2882); Computer System Security Problem (2899)
Patient Problem Not Applicable (3189)
Event Date 06/27/2018
Event Type  malfunction  
Manufacturer Narrative
Siemens is in the process of investigating these potential cyber security vulnerabilities.
 
Event Description
Siemens received a notification from an external product security researcher of some potential cyber security vulnerabilities with the rapid point 405 analyzer.There was no report of injury for this event.
 
Manufacturer Narrative
Siemens published a customer bulletin (b)(4) for these cybersecurity vulnerabilities in older operating systems which are no longer manufactured, no longer supported by (b)(4) and near their end of service support.
 
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Brand Name
RAPIDPOINT 405 BLOOD GAS ANALYZER
Type of Device
RP 405
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS
511 benedict avenue
tarrytown NY 10591
MDR Report Key7698815
MDR Text Key114688164
Report Number3002637618-2018-00079
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
PMA/PMN Number
K020616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 10/01/2018
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 Catalogue Number10322347
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/27/2018
Initial Date FDA Received07/18/2018
Supplement Dates Manufacturer Received09/28/2018
Supplement Dates FDA Received10/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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