Sentec Digital Monitor SDMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640121880018), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).

14 other recalls cover devices cleared under the same FDA submission (K041548, K071672, K101690, K151329); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Unintended Electrical Shock

  An incident occurred with Sentec SDM device (SN: (b)(6) in which one of the employees of the Munich Firebrigade (Germany) received an electric shock.The device was mounted on a stretcher together with an incubator and other associated equipment. The monitor was to be detached from the stretcher. While doing so, the employee touched the rear of the device and received an electric shock. A minor burn mark was visible on her hand, and both the residual current device (RCD) of the stretcher and the RCD of the station tripped.The device was then disconnected from the mains and taken out of service.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50927937 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041548, K071672, K101690, K151329. One submission often covers many models, so check the product and lot details in each record.

• Z-2592-2023 · Jul 25, 2023 · Open, Classified
  Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-
• Z-1980-2023 · May 2, 2023 · Open, Classified
  V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
• Z-0148-2023 · Aug 22, 2022 · Terminated
  sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
• Z-1134-2021 · Dec 10, 2020 · Terminated
  SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxy
• Z-2155-2019 · May 2, 2019 · Terminated
  SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as
• Z-2152-2019 · May 2, 2019 · Terminated
  SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen sa
• Z-2154-2019 · May 2, 2019 · Terminated
  SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxyge
• Z-2156-2019 · May 2, 2019 · Terminated
  SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturatio
• Z-2153-2019 · May 2, 2019 · Terminated
  SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxyge
• Z-0088-2017 · Sep 15, 2016 · Terminated
  SDMS (SenTec Digital Monitoring System)
• Z-1501-2015 · Mar 25, 2015 · Terminated
  Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for conti
• Z-0433-2013 · Nov 5, 2012 · Terminated
  SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with
• Z-0434-2013 · Nov 5, 2012 · Terminated
  SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor
• Z-2199-2012 · Jul 9, 2012 · Terminated
  SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).