Membrane Changer Set

• EUDAMED Basic UDI-DI 764012188MCSR registered 12 Nov 2021 Active
• FDA 510(k) K151329 decided 17 Dec 2015 Active· +3 more in the status table
• FDA GUDID UDI-DI 07640121880490 listed 31 Aug 2016 Listed

• • Ongoing Z-2592-2023 FDA Class II ·initiated 25 Jul 2023

  During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

• • Ongoing Z-1980-2023 FDA Class II ·initiated 2 May 2023

  The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

• • Terminated Z-0148-2023 FDA Class II ·initiated 22 Aug 2022

  Weak skin adhesion.

• • Terminated Z-1134-2021 FDA Class II ·initiated 10 Dec 2020

  Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

• 5 recalls, same reason

  • Terminated Z-2154-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2155-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2153-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2152-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2156-2019 FDA Class II ·initiated 2 May 2019

  There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

• • Terminated Z-0088-2017 FDA Class II ·initiated 15 Sep 2016

  Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

• • Terminated Z-1501-2015 FDA Class II ·initiated 25 Mar 2015

  SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens

• 2 recalls, same reason

  • Terminated Z-0434-2013 FDA Class II ·initiated 5 Nov 2012
  • Terminated Z-0433-2013 FDA Class II ·initiated 5 Nov 2012

  A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

• • Terminated Z-2199-2012 FDA Class II ·initiated 9 Jul 2012

  SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

1. 2 May 2019 Recall initiated FDA recalls Z-2154-2019
2. 2 May 2019 Recall initiated FDA recalls Z-2155-2019
3. 2 May 2019 Recall initiated FDA recalls Z-2153-2019
4. 2 May 2019 Recall initiated FDA recalls Z-2152-2019
5. 2 May 2019 Recall initiated FDA recalls Z-2156-2019
6. 10 Dec 2020 Recall initiated FDA recalls Z-1134-2021
7. 12 Nov 2021 Registered EUDAMED 764012188MCSR
8. 22 Aug 2022 Recall initiated FDA recalls Z-0148-2023
9. 2 May 2023 Recall initiated FDA recalls Z-1980-2023
10. 25 Jul 2023 Recall initiated FDA recalls Z-2592-2023

10 earlier events are in the sections above.

Generic name

Transcutaneous blood gas monitoring system

Model / reference

MC-SET

Primary DI / UDI-DI

07640121880490

Basic UDI-DI

764012188MCSR

Direct marketing DI

07640121880490

510(k) Number

K041548 ↗

K071672 ↗

K101690 ↗

K151329 ↗

FDA product code

DPZ, DQA, KLK, LKD, LPP

EMDN code

Z1203020405 Transcutaneous po2/pco2 monitors

GMDN term

Transcutaneous blood gas monitoring system

Device class

Class I EUDAMED

Class II GUDID

Regulation number

870.2710, 870.2700, 868.2500, 868.2480

EU registration type

Standard device

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

EUDAMED SRN

CH-MF-000008058

Authorised representative

Sentec GmbH DE-AR-000007618

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