TCM CombiM module 903-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05700699031112), received between Aug 14, 2020 and Aug 14, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A SET OF TWINS 32 WEEKS OF AGE WERE MONITORED BY TWO TCM COMBIN MONITORS (SERIAL NUMBERS (B)(6) AND (B)(6)). TWIN (A) APPEARED TO HAVE A BRUISE ON HER OUTER THIGH. THE CUSTOMER ALSO STATES THAT THIS PATIENT HAS SIMILAR DEEP RED MARKS BILATERALLY AS WELL ON HER BACK; UP BY HER SHOULDERS. THE OTHER TWIN (B) HAD NO CONCERNS OR ISSUES AT THIS TIME. THE CUSTOMER REACHED OUT FOR A WOUND CONSULT WHO RECOMMENDED TO USE RADIOGEL SHEETS EVERY 2 TO 3 DAYS AND FOLLOW UP. BOTH MONITORS WERE TAKEN OFF THE PATIENTS AND NO LONGER IN SERVICE. THE CUSTOMER STATES SHE DOES NOT KNOW WHICH MONITOR WAS ON EACH TWIN, BUT THE MONITOR ENDING IN N005 WAS SET TO 44 DEGREES C, SITE TIME SET TO 6 HOURS, AND THE CO2 ALARM IS SET TO OFF. THE MONITOR ENDING IN N006 WAS SET TO 42 DEGREES. HAVE NOT CONFIRMED IF THE CO2 ALARM WAS ON OR OFF OR THE LENGTH OF TIME SET ON THE SITE TIME. BOTH MONITORS TIME AND DATE WAS INCORRECT. THE SENSOR PLACEMENT ON TWIN A WAS ALTERNATING BETWEEN OUTER LEGS BEGINNING AT 1030 AM ON (B)(6) TO (B)(6). ON (B)(6) THE SENSOR PLACEMENT CHANGED TO THE BACK FOR APPROX. FOR 6 HOURS UNTIL IT WAS REMOVED OFF OF TWIN A ON THE MORNING OF (B)(6). AT THIS TIME BOTH MONITORS WERE TAKEN OFF OF BOTH BA

  Patient problems: Burn, Thermal

  MAUDE report 10407704 ↗
• InjuryAug 14, 2020Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  A SET OF TWINS 32 WEEKS OF AGE WERE MONITORED BY TWO TCM COMBIM MONITORS (SERIAL NUMBERS (B)(4)). TWIN (A) APPEARED TO HAVE A BRUISE ON HER OUTER THIGH. THE CUSTOMER ALSO STATES THAT THIS PATIENT HAS SIMILAR DEEP RED MARKS BILATERALLY AS WELL ON HER BACK; UP BY HER SHOULDERS. THE OTHER TWIN (B) HAD NO CONCERNS OR ISSUES AT THIS TIME. THE CUSTOMER REACHED OUT FOR A WOUND CONSULT WHO RECOMMENDED TO USE RADIOGEL SHEETS EVERY 2 TO 3 DAYS AND FOLLOW UP. BOTH MONITORS WERE TAKEN OFF THE PATIENTS AND NO LONGER IN SERVICE. THE CUSTOMER STATES SHE DOES NOT KNOW WHICH MONITOR WAS ON EACH TWIN, BUT THE MONITOR ENDING IN N005 WAS SET TO 44 DEGREES C, SITE TIME SET TO 6 HOURS, AND THE CO2 ALARM IS SET TO OFF. THE MONITOR ENDING IN N006 WAS SET TO 42 DEGREES. HAVE NOT CONFIRMED IF THE CO2 ALARM WAS ON OR OFF OR THE LENGTH OF TIME SET ON THE SITE TIME. BOTH MONITORS TIME AND DATE WAS INCORRECT. THE SENSOR PLACEMENT ON TWIN A WAS ALTERNATING BETWEEN OUTER LEGS BEGINNING AT 1030 AM ON 7/15 TO 7/16. ON 7/17 THE SENSOR PLACEMENT CHANGED TO THE BACK FOR APPROX. FOR 6 HOURS UNTIL IT WAS REMOVED OFF OF TWIN A ON THE MORNING OF 7/17. AT THIS TIME BOTH MONITORS WERE TAKEN OFF OF BOTH BABIES.

  Patient problems: Burn, Thermal; Partial thickness (Second Degree) Burn

  MAUDE report 10406799 ↗