Multi-Site Attachment Ring for mature/intact skin MARe-MIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640121880797), received between Dec 24, 2021 and Dec 24, 2021 — classified as 1 death.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• DeathDec 24, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, NURSING OBSERVED A NEONATE WITH INFECTED WOUND, WHICH DEVELOPED A DEEP ABDOMINAL WALL NECROSIS ON THE RIGHT ABDOMEN. SENTEC WAS INFORMED 10-NOV-2021, RECEIVED INCOMPLETE INFORMATION UNTIL 29-NOV-2021. SENTEC WAS NOTIFIED OF DEATH 06-DEC-2021. NEONATE WITH INFECTED WOUND, WHICH DEVELOPED A DEEP ABDOMINAL WALL NECROSIS ON THE RIGHT ABDOMEN. THE NEONATE WAS BORN AT THE GESTATIONAL AGE OF (B)(6) AND WAS (B)(6) OLD AT THE TIME OF THE EVENT. THE PATIENT WAS EXTREMELY PREMATURE AND AT HIGH RISK. THE PATIENT HAD VERY TRANSLUCENT AND FRAGILE SKIN. FROM THE DESCRIPTION OF THE EVENT AND THE ATTACHED PICTURES PROVIDED TO THE MANUFACTURER, IT IS NOT CONCLUSIVE AS TO WHAT CAUSED THE WOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE PATIENT WAS UNDER HIGH-HUMIDITY AND BEING HYDRATED ON (B)(6) 2021. THE MEASUREMENT SITE ON THE RIGHT ABDOMEN WAS USED FOR THE LAST TIME ON (B)(6) 2021. AFTER (B)(6) 2021, THE SENSOR WAS PLACED ON OTHER BODY LOCATIONS ON THE LEFT ABDOMEN AND THIGHS. NURSES DID NOT DOCUMENT ANY CONCERN ON THAT DATE AND SKIN COLOR WAS CHARTED AS NORMAL ON THE PRIOR DAY. NO PRESSURE OR ADDITIONAL TAPE WAS USED. THE CARE TEAM HAD CHANGED THEIR CARE FOR THE

  Patient problems: Localized Skin Lesion

  MAUDE report 13083569 ↗

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-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-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-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-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-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).