inforMED
DeathNPF

SMARTMONITOR 2

Received May 28, 2009 · Event occurred Jul 7, 2006

Report MW5011241 · MDR key 1396183

Device

Generic name

None

Manufacturer

Respironic

Model number

SMARTMONITOR 2

Catalog number

*

Lot number

300005285

Product problems

  • Device Alarm System
  • Replace

Patient

5 YR

  • Death
  • Respiratory arrest

Narrative

Description of Event or Problem

MY DAUGHTER USED THE SMARTMONITOR 2. THE ALARM DID NOT SOUND AND THE CHILD DIED. THIS WAS THE THIRD THEY GAVE ME, THE OTHER TWO DID NOT SOUND. THERE WERE USED 3 SMARTMONITOR IN 2 MONTHS AND THE THREE FAILED. DATES OF USE: 3 DAYS, 2006. DIAGNOSIS: STOP BREATHING.