National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA)
Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation
Date of issue: 23 September 2020
Reference No: NatPSA/2020/007/MHRA
This alert is for action by: all hospital trusts and other healthcare providers using the affected ventilators.
This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by an executive leader (or equivalent role in organisations without executive boards), supported by their clinical lead for critical care and heads of procurement.
Explanation of identified safety issue
In March 2020 Philips Health Systems released an FSN concerning V60 ventilators. This FSN concerned a hardware fault in the device, which can result in an unexpected shutdown.
There are 2 ways in which this shutdown can occur:
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The first will sound a warning to alert the user that the machine is shutting down. This will let the user know they need to switch to an alternative source of ventilation. There is a risk that the patient will be unventilated while this second source of ventilation is prepared.
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The second failure mode will cause the device to shut down with no warning to the user. If a device fails in use and does not alarm, the patient will not be adequately ventilated and there is a potential risk of brain damage or death, depending on how long it takes clinicians to become aware of the situation and respond.
There has been a significant delay of replacement parts arriving in the United Kingdom, resulting in an increased risk of this failure occurring. The MHRA has decided to update the guidance issued in the Medical Device Alert published in June.
The MHRA will continue to work with the manufacturer to improve the delivery time for replacement components.
See additional information for the complete list of affected device serial numbers.
Actions required
Primary actions to be completed by 7 October 2020
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Identify and locate affected devices in your organisation
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Identify alternative ventilators available on site
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If no suitable alternative available, and capacity is an issue currently or expected imminently, follow protocol for resource shortage escalation set out by your local governance
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Train all relevant staff on alternative ventilators and ensure training records are up to date
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When actions 1–4 are complete, remove affected V60s from use and quarantine until repaired by the manufacturer
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Place the alternative devices into service in place of the affected V60s
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You may continue to use affected V60s if there is a risk of severe patient harm due to lack of ventilator availability. A thorough risk assessment must be completed, and additional monitoring must be used. A backup form of ventilation must be available at all times
Secondary action to be completed by 23 December 2020
8.Review procurement and stock policies to ensure you are not reliant on one manufacturer or model of ventilator
Additional information
Notes
List of affected device serial numbers. Note some cells include a range of numbers so exercise caution when identifying affected devices:
- 100002908 to 100017733
- 100019389 to 100022246
- 100023220 to 100108298
- 100109211 to 100110991
- 100113082
- 100113271
- 100116388
- 100118560
- 100118889
- 100119580
- 100121701
- 100126907
- 201000040 to 201007766
- 201009257
- 201010952
The above ventilators must also have the Power Management PCBA part number 1055906 to be affected. Some of the ventilators listed above may have already had the Power Management PCBA replaced through the normal service process.
Manufacturer contact details: Philips Respironics Tel: 0870 532 9741 email: safetynoticeuki@philips.com
Protocol for resource shortage escalation
- England - Trusts in England should read our guidance on resource shortage escalation
- Scotland - Health Boards in Scotland should contact National Procurement to discuss Covid-19 pandemic ventilator supply (if required). National Procurement contact details are: Kate Henderson, email:kate.henderson@nhs.scot, telephone: 0781 353 1487 or Laura Santi, email: laura.santi@nhs.scot, telephone: 0797 046 2900
- Wales - Please contact CriticalCare@gov.wales for guidance
- Northern Ireland - There are no known affected devices in Northern Ireland. If you have one of these devices in Northern Ireland please contact niaic@health-ni.gov.uk
Stakeholder engagement
- UK National Clinical Engineering Network
- Welsh Government (Haz-Aic@gov.wales)
- Surgical Materials Testing Laboratory (SMTL)
- Incident Reporting & Investigation Centre (IRIC) NHS National Services Scotland (NSS.iric@nhs.scot)
- Northern Ireland Adverse Incident Centre (NIAIC) (niaic@health-ni.gov.uk)
- Surgical Materials Testing Laboratory (SMTL)
- The Department of Health and Social Care (MDCC-CCIM@dhsc.gov.uk)
- NHS England and NHS Improvement
Advice for Central Alerting System (CAS) officers and risk managers
This is a safety critical and complex National Patient Safety Alert. In response to CHT/2019/001 your organisation should have developed new processes to ensure appropriate oversight and co-ordination of all National Patient Safety Alerts. CAS officers should send this Alert to the executive lead nominated in their new process to coordinate implementation of safety critical and complex National Patient Safety Alerts.
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