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Manufacturers’ Field Safety Notices
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Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
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 24/06/24 – 28/06/24
- B Braun: Spaceplus Infusomat 45467 Bedside infusion pump, single-channel MHRA reference: 30931286 2024/006/024/601/011
- Baxter: iLED 7 Surgical Lights 45464 Operating Light MHRA reference: 30919404 2024/006/019/601/118
- Getinge: Advanta VXT and Flixene Vascular Graft 45464 Synthetic Vascular Graft MHRA reference: 30959662 2024/005/030/601/090
- Philips: BiPAP A30 Ventilator (Respironics, Inc.) BiPAP A40 45433 Portable electric ventilator MHRA reference: 30458851 2024/003/027/601/074
- SCHILLER MEDICAL: DEFIGARD Touch7 45444 Monitor Defibrillator MHRA reference: 30972900 2024/006/028/601/011
- Siemens Healthineers: Luminos dRF/Lotus Max XP017-24-S, XP018-24-S, XP019-24-S Interventional fluoroscopic x-ray system Model: 10762471, 11574100 MHRA reference: 30958391 2024/006/026/601/026
- Stryker: SYNCHRO Guidewires 45444 MHRA reference: 30948961 2024/006/007/601/071
- Zimmer Biomet: CPT 45474 Uncoated hip femur prosthesis, one-piece MHRA reference: 31016779 2024/007/001/601/031
- ZOLL: 731 Ventilator – for MRI Compatible Devices FSCA 2024-04-01 MHRA reference: 30950986 2024/004/029/601/103
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/
Incident Reporting & Investigation Centre (IRIC)
Facilities Division
NHSScotland Assure
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts | IRIC | Turas Learn
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 about our services at www.nss.nhs.scot
FAC406-212, 8B(i), Rev 7
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