CM5000
Received Nov 1, 1993 · Event occurred Aug 26, 1993
Report 1317346-1993-00003 · MDR key 10424
Device
Generic name
Airway Pressure Monitor
Manufacturer
Canadian Monaghan LimitedModel number
CM5000Catalog 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.