inforMED
InjuryCAP

CM5000

Received Nov 1, 1993 · Event occurred Aug 26, 1993

Report 1317346-1993-00003 · MDR key 10424

Device

Generic name

Airway Pressure Monitor

Model number

CM5000

Catalog number

81100

Lot number

H1150

Product problems

  • Device Alarm System
  • Battery charger, defective
  • Disassembly

Patient

16 YR

  • Apnea
  • Respiratory Distress

Narrative

Description of Event or Problem

HOME HEALTH CAARE WORKER REMOVED ONE AIRWAY PRESSURE MONITOR AND CONNECTED UNIT RETURNED FROM REPAIR, PRIOR TO OPERATIONAL CHECK-OUT, TO PATIENT. UNIT FAILED TO ALAARM WHEN PATIENT STOPPED BREATHING. PATIENT TURNED BLUE BUT WAS ATTENDED TO BY THE HOME HEALTH CARE WORKER ESTIMATES THAT ONE MINUTE PASSED FROM THE TIME SHE NOTICED THE ATIENT IN DISTRESS. THE PATIENT IS MENTALLY RETARDEDD WITH MULTIPLE HEALTH PROBLEMS. CURRENTLY BEING TREATED FOR RESPIRATORY AILMENT WHICH HAS PRODUCED THICK SECRETIONS WHICH TH EHEALTH CARE WORKER STATES BLOCKED THE TRACH.