Anesthesia System Recall – SW & USB port charging

“Spacelabs Healthcare is recalling the ARKON Anesthesia System with Version 2.0 Software due to a software defect. This software issue may cause the system to stop working and require manual ventilation of patients. In addition, if a cell phone or other USB device is plugged into one of the four USB ports for charging, this may cause the system to stop working. …The error is triggered by the combination of a spirometry loop save and a change in waveform configuration.This defect may cause serious adverse health consequences, including hypoxemia and death.”
Stan Hamilton of SoftewareCPR comments:”For devices that must fail operational or risk a hazardous situation, such as this one, one should always be on the lookout for single faults that could result in an interruption of essential functionality. The safe state for these devices is generally to continue critical operations, and possibly generate an alarm or warning to resolve the fault. Isolating critical processing modules from peripheral functionality can be an important aspect to consider in achieving the desired safety model.”

Brian Pate of SoftwareCPR comments: “Have you considered various types of testing? This failure mode is a reminder that combinatorial testing is critically important with multi-featured software devices. Ensure that your module, integration, and system level testing have adequate diversity of test types particularly around risk controls and primary operating functions.”

SoftwareCPR can provide assessments of your risk mitigation and test strategy and provide valuable feedback to gain greater test effectiveness in the most efficient manner. Contact us today to discuss how we could help.

The full FDA notice is at the link provided.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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