MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1265 BLOOD GAS ANALYZER; RL 1265

Catalog Number 10321852

Device Problem Application Security Problem (2882)

Patient Problem Not Applicable (3189)

Event Date 12/25/2018

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 lab 1200 analyzer.There was no report of injury for this event.

Manufacturer Narrative

Siemens published a siemens security advisory notice (ssa-(b)(4)) for these cyber security vulnerabilities.This advisory notice is posted on the siemens product cert.Website.

• Brand Name: RAPIDLAB 1265 BLOOD GAS ANALYZER
• Type of Device: RL 1265
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 7215790
• MDR Text Key: 98404317
• Report Number: 3002637618-2018-00009
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: K073537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10321852
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1