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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
Section 2: medical devices 10/07/23 – 14/07/23
- Cook Medical: Fusion Lithotripsy Extraction Basket 45107 Biliary/urinary stone retrieval basket, single use MHRA reference: 5356601
- Draeger: Infinity CentralStation, Infinity M300/M300+ 45078 Physiological Monitoring Systems Model: MS25707, MS32504, MS25755, MS26031, MS26076, MS33659, MS32504, MS33648, 8606700, MS18267, MS18384, MS18500, MS18501, MS18501, MS18620, MS18623, MS20261, MS20464, MS20465, MS25707 MHRA reference: 5356473
- GE Healthcare: Giraffe Omnibed Carestation CS1; Giraffe Omnibed 45105 Incubator, infant, stationary MHRA reference: 5356719
- Intersurgical: NIV ANGLED MOUTHPIECE WITH NOTCH 22M/15F 45119 Breathing mouthpiece, single-use MHRA reference: 5359733
- Intuitive: da Vinci Xi and da Vinci X Surgical System ISIFA2022-14-C Robotic Surgical System Model: IS4000 Surgical System; IS4200 Surgical System MHRA reference: 5350114
- Medtronic: GRANVIA-C, IMPIX ALIF, IMPIX MANTA, IMPIX MANTA+ 45108 MHRA reference: 5359517
- Quanta: Blood Tube Sets 45120 Haemodialysis tubing set, single use MHRA reference: 5359203
- Smiths Medical: Medex extension sets 45117 Model: MX618CZ MHRA reference: 5359718
- Surgical Innovations: YelloPort Elite 5mm Optical Trocar 45117 MHRA reference: 5357809
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.
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)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575|nss.iric@nhs.scot | Report an incident | Find safety alerts
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
FAC406-015, 8B(i), Rev 6
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