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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
1.Product Recall: Facemoon Face Mask and Filters sold via Amazon (2403-0207)
2.Product Recall: Kinderkraft I-CARE Car Seat (2406-0091)
Section 2: medical devices 01/07/24 – 05/07/24
- bioMérieux: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel 45476 Multiple gastrointestinal pathogen nucleic acid IV Model: RFIT-ASY-0116 (GI, 30-pack) ; RFIT-ASY-0104 (GI, 6-pack) MHRA reference: 31017681
- Boston Scientific: Vercise Genus Implantable Pulse Generator System 45476 Deep brain electrical stimulation system Model: DB-1216 and DB-1232 MHRA reference: 31048718
- Dedalus: MedChart 45464 MHRA reference: 31050696
- HYPHEN BioMed: PT-Phen LRT 45457 Prothrombin time (PT) IVD, kit, clotting MHRA reference: 31101702
- Medtronic: Puritan Bennett 520/560 Ventilator FA1380 Portable electric ventilator MHRA reference: 30984100
- Philips: IntelliVue MX400-550 Patient Monitors 45468 Model: 866060, 866062, 866064, 866066 MHRA reference: 31038119
- werfen: Panocell-10, Ficin-Treated 45468 MHRA reference: 31005189
- Zhejiang Innuovo Rehabilitation Devices: Innuovo(Power Wheelchair) 45412 Model: N5909 MHRA reference: 30963270
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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