PORTEX PRESSUREEASY CUFF PRESSURE MONITOR
Received Mar 23, 2022 · Event occurred Feb 21, 2022
Report 3012307300-2022-05071 · MDR key 13862748
Device
Generic name
Meter, Airway Pressure (inspiratory Force)
Manufacturer
St PaulCatalog number
100/568/000
Lot number
4180778
Product problems
- Device Emits Odor
- Device Emits Odor
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE DEVICE WAS RECEIVED FOR EVALUATION IN RELATION TO THE REPORTED EVENT. SENSORY INSPECTION OF THE DEVICE WAS UNABLE TO CONFIRM THE REPORTED EVENT. REPORTED UNUSUAL ODOR WAS NOT NOTICED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE REPORTED EVENT WAS NOT CONFIRMED. A DHR REVIEW WAS NOT PERFORMED AS IT WAS NOT NECESSARY FOR THE INVESTIGATION OF THE REPORTED EVENT.
Description of Event or Problem
IT WAS REPORTED THAT UPON OPENING THE DEVICE HAD A BAD SMELL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.