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Manufacturers’ Field Safety Notices
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This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers.
This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.
You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below but have not received it from them. This will help ensure that you are not also missed from future FSN distributions. Note that field safety notices will only be listed in the sections below if we have been made aware of them.
Section 1 below lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS). Section 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).
Section 1: estates, facilities or general products
None
Section 2: medical devices 23/09/24 – 27/09/24
- Abbvie: Lacrilube 17th September 2024 Model: 7982X MHRA reference: 32703315 2024/009/017/601/054
- Actim: Actim PARTUS TEST 10th September 2024 Insulin-like growth factor binding protein 1 IVD MHRA reference: 32703444 2024/009/023/601/022
- Ambu: Ambu® VivaSight™ 2 DLT 16th September 2024 Endobronchial tube MHRA reference: 32734283 2024/008/030/601/030
- Blink Medical : Yankauer Suction Tube 17th September 2024 Model: HR755 MHRA reference: 32721754 2024/009/017/601/019
- Medtronic: Percept™ RC 45536 DEEP BRAIN STIMULATION (DBS) Model: B35300 MHRA reference: 32721888 2024/009/024/601/014
- Medtronic: Recharger Kit 45536 Cerebral Implantable Neurostimulator – Accessories Model: RS6230 (EMDN: J020180), RS7230 (EMDN: J020280) MHRA reference: 32722204 2024/009/018/601/032
- Mindray : V90 electronic vaporizer 19th July 2024 MHRA reference: 32734483 2024/007/018/601/020
- Respironics: BiPAP A30 Ventilator (Respironics, Inc.) BiPAP A40 16th September 2024 Portable electric ventilator Model: Please refer to Device Affected List MHRA reference: 32715628 2024/003/027/601/074
- Smiths Medical: AC Adapter CADD Solis 26th September 2024 Basic power supply, reusable Model: 21-0270-25 MHRA reference: 32703381 2024/009/023/601/012
The above list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here.
Section 3: updates and changes to previously published medical device FSNs
| Page summary | Change(s) made |
| n/a | n/a |
Adverse Incidents
Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 test kit
- Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
- Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
- Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Kind regards
Incident Reporting & Investigation Centre (IRIC)
NHSScotland Assure
NHS National Services Scotland
IRIC operates incident learning and prevention systems for medical devices, IVDs, estates, facilities, social care equipment and PPE
Tel: 0131 275 7575 | nss.iric@nhs.scot | report incidents | safety alerts | Turas Learn | Intro to IRIC short video
We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026
FAC406-212, 8B(i), Rev 7
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