Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.01.2019 – 31.03.2019

Опубліковано 27.06.2019 о 11:34

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

 

Manufactured by Fresenius Medical – inadequate ultrafiltration can occur due to sudden failure of the ultrafiltration (UF) pump.

Alert type: Medical device alert Issued: 29 March 2019

Manufactured by Philips – this problem affects lithium ion batteries that have exceeded their specified replacement interval or number of charging cycles.

Alert type: Medical device alert Medical specialism:   Anaesthetics and 16 others  Issued:20 March 2019

Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

 Medical device alert Medical specialism: Anaesthetics and 14 others Issued:19 March 2019

[Archived] Manufactured by Vyaire – Cartridges with an aluminium warming plate in the fluid pathway can lead to an IV infusion containing aluminium above currently recommended safe levels.

Alert type:

 Medical device alert Medical specialism: Anaesthetics and 14 others Issued: 19 March 2019

Manufactured by C.R.

Alert type: Medical device alert

 Medical specialism: Obstetrics and gynaecology and 2 others

Issued:7 March 2018

[Archived]Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – additional suitable battery identified for use in the T34 pump

Alert type: Medical device alert

 Medical specialism:  Care home staff and 3 others  Issued:14 November 2018

Manufactured by Caesarea Medical Electronics (CME) Ltd, a BD company – instructions provided to reduce the risk of delay to therapy and loss of infusion if the battery loses connection.

Alert type: Medical device alert

 Issued: 4 March 2019

Manufactured by ConvaTec Limited – use of affected devices may increase risk of patients acquiring infections – extension to MDA/2018/034 as additional devices are affected

Alert type:  Medical device alert Medical specialism: Anaesthetics and 15 others

 Issued:28 February 2019

Manufactured by GE Healthcare – If networks are incorrectly configured with multiple monitors, a prolonged bandwidth overload condition may occur and cause monitors to restart

Alert type:  Medical device alert  Medical specialism: Anaesthetics and 14 others

 Issued: 27 February 2019

Manufactured by Stryker – potential for a lock-up condition where the device becomes non-responsive after a defibrillation shock has been delivered.

Alert type:

 Medical device alert  Medical specialism:  Anaesthetics and 18 others  Issued:20 February 2019

Manufactured by Roche Diabetes Care – Important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).

Alert type: Medical device alert

 Medical specialism:  Care home staff and 4 others  Issued: 19 February 2019

Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (MDA/2019/008)

Alert type:

 Medical device alert  Medical specialism:  Anaesthetics and 5 others

 Issued: 13 February 2019

Manufactured by ReVision Optics, Inc – patients implanted with this device have an increased risk of corneal haze.

Alert type:  Medical device alert  Medical specialism:  General practice and 2 others

Issued: 13 February 2018

Manufactured by Stryker – post-operative loosening of the implant which may require revision surgery.

Alert type:

 Medical device alert  Issued:  8 February 2019

Manufactured by Eurotrol B.V – may give readings below the values assigned to the product, leading to incorrect measurement results.

Alert type:Medical device alert 

Medical specialism:  Anaesthetics and 21 others  Issued: 30 January 2019

Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.

Alert type:

 Medical device alert  Medical specialism:  Care home staff and 1 others  Issued: 30 January 2019

Endologix has stopped selling the Nellix EVAS device and is recalling unused stock.

Alert type:  Medical device alert 

Medical specialism:  Radiology and 1 others n Issued: 25 January 2019

Manufactured by Abbott – some users who are experiencing an immune response to the adhesive are applying creams, patches or sprays under their sensor to reduce skin reactions, which may affect device performance.

Alert type: Medical device alert 

Medical specialism: Care home staff and 3 others Issued:29 January 2019

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