PORTEX CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES
Received Jan 11, 2019
Report 3012307300-2019-00187 · MDR key 8241484
Device
Generic name
Monitor, Airway Pressure (includes Gauge And/or Alarm)
Catalog number
100/568/000
Lot number
3423245
Product problems
- Output Problem
- Output Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CUFF INFLATOR HAS A PENDANT POINTER. THE TIP IS TOUCHING THE CUFF INFLATOR SURFACE.
Additional Manufacturer Narrative
ONE CUFF INFLATOR PRESSURE GAUGE WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, DEVICE FOUND TO BE GOOD PHYSICAL CONDITION. DEVICE UNDERWENT FUNCTIONAL TESTING WHICH INCLUDED CLOSING THE INFLATION PORT WITH FINGER, WHILE PRESSING CUFF INFLATOR 30 TIMES REPEATEDLY. AS A RESULT, THE REPORTED CUSTOMER COMPLAINT WAS NOT CONFIRMED. WHILE NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.