inforMED
DeathNPF

RESPIRONICS

Received Apr 30, 2009 · Event occurred Dec 8, 2007

Report MW5011102 · MDR key 1386553

Device

Generic name

Apnea Monitor

Manufacturer

Respironics

Model number

#2 SMART MONITOR

Product problems

  • Loss of Power
  • Self-Activation or Keying

Patient

1 MO

  • Death
  • Identified diagnosis

Narrative

Description of Event or Problem

IN 2007, A MALE PT. THEY CHOSE TO PUT AN APNEA ON HIM - THEY WANTED IT CONTINUED AT HOME. THIS MACHINE WAS TOTALLY UNRELIABLE GOING OFF WHEN SHOULDN'T. THEY STATED IN THE PAPER "THE CHIP WAS NEVER ON". SIMPLY NOT TRUE. JUST IN THIS TOWN WE HAVE 20 PEOPLE WITH THE SAME EXISTING PROBLEMS - WE'VE PUT IN ON THE INTERNET AND YOU WOULDN'T BELIEVE THE RESPONSE. WE ARE GATHERING MUCH INFORMATION - THIS AGENCY HAS EVEN IGNORED THE CORONERS REPORT OF SIDS AND EVEN HE SAID "THESE MACHINES ARE UNRELIABLE". THEY ARE CHARGING MY SON AND DAUGHTER-IN-LAW WITH NEGLECT. DOSE OR AMOUNT: USE AS NEEDED. FREQUENCY: 24/7. DATES OF USE: 2007. DIAGNOSIS: SUPPOSED HIGH RISK BREATHING PROBLEM. SECOND MONITOR THE MONTH PRIOR. TWO WEEKS PRIOR, HOSPITAL HAS OWN APNEA MACHINE USED TILL NINE DAYS LATER. SENT HOME.