inforMED
MalfunctionFOH

TCMATT

Received Jul 9, 2025 · Event occurred Apr 1, 2025

Report 22456456 · MDR key 22456456

Device

Generic name

Mattress, Water, Temperature Regulated

Model number

NEOSINGLE

Catalog number

6427401

Product problems

  • Leak/Splash
  • Defective Device

Patient

NA · Unknown

  • Hypothermia
  • Hypothermia

Narrative

Description of Event or Problem

INFANT WAS ON TECOTHERM FOR THERAPEUTIC HYPOTHERMIA, REWARMING PHASE STARTED AT 1902. AT 1945 AFTER CARES NOTED LARGE WET SPOT ON BLANKED ON BED AT THE BOTTOM, NEAR THE CONNECTION PORT OF THE MATTRESS. CHARGE RN CALLED TO BEDSIDE TO HELP ASSESS. FOUND VERY TINY HOLE IN THE MATTRESS AT THE CORNER EDGE NEXT TO WHERE THE HOSES CONNECT. DISCUSSED CHANGING OUT MATTRESS, BUT SINCE SHE ONLY HAD A FEW MORE HOURS OF REWARMING TRIALED TAPING OVER THE SITE AND PLACED A CHUCKS PAD UNDERNEATH. NO FURTHER LEAKING NOTED, INFANT-MAINTAINED CORE TEMPS PER REWARMING PHASE. SAVED MATTRESS FOR MANAGEMENT AFTER WARMING PHASE COMPLETED AND TECOTHERM DISCONTINUED. SITE CONFIRMED DEFECT, [REDACTED] REPLIED ASKING FOR PRODUCT IDS. [DATE REDACTED] SENT ON UPS TRK# [REDACTED]. MANUFACTURER RESPONSE FOR TECOTHERM DISPOSABLE AQUA WRAP, TECOTHERM DISPOSABLE AQUA WRAP (PER SITE REPORTER). [REDACTED] SENT ON UPS TRK# [REDACTED].