inforMED
MalfunctionFTY

HOLTAIN HIGH SPEED STADIOMETER

Received Dec 5, 2025 · Event occurred Aug 19, 2025

Report 23728408 · MDR key 23728408

Device

Generic name

Tape, Measuring, Rulers And Calipers

Manufacturer

Seritex Inc.

Product problems

  • Calibration Problem
  • Device-Device Incompatibility

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NO HARM TO PATIENT. MORE THAN A MONTH AGO, THE STADIOMETER IN OUR PEDIATRIC SATELLITE OFFICE IN EP [ELECTROPHYSIOLOGY] BECAME OFF TRACK AND UNABLE TO CALIBRATE. WE HAD BMET [BIOMEDICAL EQUIPMENT TECHNICIAN] MAKE SEVERAL TRIPS TO THE SITE AND UNABLE TO REPAIR. IT WAS DEEMED THAT THE HIGH SPEED COUNTER WAS BROKEN AND ON [REDACTED] -APPROXIMATELY 3 MONTHS AGO, WE ORDERED A REPLACEMENT COUNTER WITH A BACKUP COUNTER AS WE HAVE SEVERAL OF THESE UNITS. ON [REDACTED] -APPROXIMATELY 2 WEEKS LATER, THE TWO COUNTERS ARRIVED AND SINCE THEN BMET HAS TRIED TO REPAIR BUT IT APPEARS THAT THE GEARS ARE NOT MATCHING UP. QUESTIONED IF THE CORRECT COUNTER WAS ORDERED/SENT AND THERE WERE SEVERAL EMAILS BACK AND FORTH ONLY TO REPORT THAT COMPANY BELIEVES THAT IT WAS THE CORRECT COUNTER ORDERED. TO DATE STILL CANNOT GET IT TO WORK. IMPACTING PATIENT CARE AS WE CANNOT OBTAIN ACCURATE HEIGHTS. COMPANY NOT QUICKLY RESPONDING TO EMAILS. HAVE ALSO TRIED CALLING AND SENT PHOTOS OF THE COUNTER. COMPANY CONTINUES TO BELIEVE IT IS THE CORRECT COUNTER, YET IT LOOKS DIFFERENT THAN THE OLD ONE AND GEARS NOT MATCHING UP. HAVE LET COMPANY KNOW THAT WE WOULD LIKE RESOLUTION WITH EITHER A PERSONAL VISIT TO THE SITE OR FACE TIME WITH BMET.