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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 13/05/24 – 17/05/24
- GE Healthcare: Centricity High Acuity Anesthesia / Critical Care Ref. # 38012 Patient health record information system MHRA reference: 30472239
- Invacare: I-Transia Ceiling Hoist 45428 Model: I-Transia MHRA reference: 30473639
- NIHON KOHDEN: Life Scope Patient Monitoring Devices 45425 Single-patient physiologic monitoring system Model: BSM-1763 MHRA reference: 30472262
- Philips: MobileDiagnost wDR 45425 Mobile basic diagnostic x-ray system, digital Model: 712007, 712006, 712004, 712002, 712005, 9890-010-89522 MHRA reference: 30469825
- Philips: Achieva 1.5T, Achieva 1.5T Conversion, Achieva 1.5 45401 Magnetic Resonance Imaging (MRI) unit Model: 781343 781296 781346 781283 781178 781345 781344 781278 781277 781177 781477 781479 781253 782116 782148 782117 782143 782140 782115 782101 781396 781341 781315 781262 781261 781347 782103 781377 781342 782105 781271 782139 782133 782108 781359 782138 782109 781356 781358 882380 781295 781474 782152 782110 781483 781439 781440 781350 782146 782112 781260 782145 782129 782113 781270 782118 781361 782127 MHRA reference: 30471132
- Philips: Trilogy EVO/ Trilogy Evo O2/ Trilogy EV300 45348 Portable electric ventilator MHRA reference: 30475739
- RRR Manufacturing Pty: CellAED Automated External Defibrillator 45428 Model: CellAED 100-2.2-094 MHRA reference: 30556731
- Smith & Nephew: REAL INTELLIGENCE CORI 45419 Robotic surgical system MHRA reference: 30455955
- TSC-UK: Fluido Trauma set Sterile 45406 Radiation/fluidwarmer intravenous set Model: 671500 MHRA reference: 30467829
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 |
| None | 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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