PORTEX CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES
Received Jan 11, 2019 · Event occurred Dec 6, 2018
Report 3012307300-2019-00159 · MDR key 8241493
Device
Generic name
Monitor, Airway Pressure (includes Gauge And/or Alarm)
Catalog number
100/568/000
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 DOES NOT RELEASE AIR. THE ARROW ON THE GAUGE DOES NOT RETURN TO 0. ANOTHER WAS USED AND NO PATIENT INJURY RESULTED.
Additional Manufacturer Narrative
INITIAL REPORT WAS FILED INADVERTENTLY. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE ACCESSORY WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THE EVENT REPORTED UNDER MDR 3012307300-2019-00159 WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER.