Field Safety Notices (FSNs): 17/06/24 – 21/06/24

Manufacturers’ Field Safety Notices

Circulation

DL1 NHS Incidents and alerts Safety Officers

DL2 Local Authority Incidents and alerts Safety Officers

DL3 Specialist Liaison Group

DL4 Product Specialists

DL5 General List

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

1. Product Recall: Noah Bunkbed and Trundle Bed and Matsen Mattress

Section 2: medical devices 17/06/24 – 21/06/24

1. Boston Scientific: Direxion Fathom-16 System Pre Loaded Torqueable 45436 Peripheral/coronary vascular microcatheter  MHRA reference: 30849154     
2. enovis: DISCOVERY HUMERAL STEMS  45450 MHRA reference: 30795588   
3. Lowenstein Medical: Leoni plus HFO / Leoni plus Transport  45460 Baby Ventilator  Model: 0217004 / 0217400  MHRA reference: 30911215   
4. Olympus: Electrosurgical Generator – ESG-410 45464 Electrosurgical Units  Model: WA91307W  MHRA reference: 30904992   
5. Proteomedix: Proclarix Risk Calculator  45460 Cancer risk assessment interpretive software IVD  MHRA reference: 30864032   
6. Stryker: Trevo Retrievers/Microcatheters/Synchro Guide wire   45413 MHRA reference: 30890492  
7. Zhejiang Innuovo Rehabilitation Devices: Innuovo(Power Wheelchair) 45443 Model: N5909 MHRA reference: 30868766

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

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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