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Published on: April 7, 2021
Malfunction of the Siaretron 1000 Iper™ hyperbaric ventilator
Pieter A Bothma1, Andreas Brodbeck, Uday Bapat
1Consultant in Anaesthesia and Intensive Care and lead consultant of the East of England Hyperbaric Unit, James Paget University Hospitals NHS Foundation Trust, Lowestoft Road, Gorleston, Norfolk NR31 6LA, United Kingdom, Phone: +44-(0)1493-452475, Fax: +44-(0)1493-452753,
Two serious malfunctions were found in the Siaretron 1000 Iper™ patient ventilator during hyperbaric testing. These issues, affecting both volume control and pressure control ventilation modes, could have severe clinical consequences if not recognized.
Area of Science:
- Biomedical Engineering
- Critical Care Medicine
- Respiratory Therapy
Background:
- Patient ventilators used in hyperbaric chambers require specialized designs due to the critical nature of their function.
- Malfunctions in such equipment can lead to severe patient harm.
- This report details two significant issues identified with the Siaretron 1000 Iper™ ventilator.
Purpose of the Study:
- To investigate and report critical malfunctions identified in the Siaretron 1000 Iper™ patient ventilator.
- To alert healthcare professionals and users about potential equipment failures not documented in the user manual.
Main Methods:
- The Siaretron 1000 Iper™ ventilator was subjected to rigorous testing.
- A Biotek VT-Plus™ gas flow analyzer was used to measure tidal volume and O2 concentration.
- A Teledyne Electronic Devices™ O2 analyzer verified changes in the fraction of inspiratory oxygen (FiO2).
Main Results:
- In Volume Control Ventilation (VCV) mode, altering the FiO2 resulted in excessive tidal volume delivery.
- In Pressure Control Ventilation (PCV) mode, changes to the FiO2 setting did not affect the delivered FiO2, and an irregular flow pattern was observed.
- The PCV malfunction was attributed to a faulty microchip on the main board.
Conclusions:
- The identified malfunctions in the Siaretron 1000 Iper™ ventilator pose significant diagnostic and clinical risks.
- A main board replacement resolved the PCV issue, while adjusting FiO2 in small increments mitigated the VCV problem.
- It is crucial for all users of this ventilator to be aware of these undocumented issues to ensure patient safety.
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