inforMED
InjuryCAP

CM5000SC

Received Oct 14, 1993 · Event occurred Jul 6, 1993

Report 1317346-1993-00001 · MDR key 10874

Device

Generic name

Airway Pressure Monitor

Model number

CM5000 SC

Catalog number

900-50SC-001

Lot number

N/A

Product problems

  • Device Alarm System

Patient

NA

Narrative

Description of Event or Problem

WHEN THE MONITOR WAS BEING SET-UP IT WOULD NOT; THENEEDLE ON THE GAUGE WAS NOT MOVING. WHEN THE UNIT WAS TESTED IN BIOMED (PRIOR TO BEING INSTALLED INTO A VENTILLATOR PATIENT SYSTEM) THE NEEDLE WOULD MOVE IRRATICALLY. THE UNIT DID NOT SOUND AN INADVERTENT OFF ALARM. THE INSTRUCTION MANUAL HAS A PROCEDURE FOR THE TESTING OF THE UNIT PRIOR TO USE.