inforMED
InjuryMHX

CARESCAPE B850 V3

Received Jun 24, 2026

Report 9610105-2026-00003 · MDR key 25614418

Device

Generic name

Monitor, Physiological, Patient

Model number

MBC313

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • High Readings

Patient

Unknown

  • Insufficient Information

Narrative

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS HELSINKI - KUORTANEENKATU 2 FINLAND HELSINKI ETELA-SUOMEN LAANI, FIN-00510. A1-6: NOT PROVIDED BY THE CUSTOMER. B3: NOT AVAILABLE AT THIS TIME. GE HEALTHCARE'S INVESTIGATION IS IN-PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING TRANSFER TO ANOTHER PATIENT ROOM, THE IBP READINGS WERE SIGNIFICANTLY LOWER THAN THOSE PROVIDED IN THE PREVIOUS ROOM (WHICH WERE NORMAL LEVEL). THE PATIENT WAS STARTED ON A NORADRENALINE INFUSION. THE CUSTOMER BELIEVES THE IBP READINGS IN THE PREVIOUS ROOM WERE INCORRECT WHICH MAY HAVE LED TO A DELAY IN TREATING THE PATIENT'S HYPOTENSION.