PORTEX HYPERINFLATION RESUSCITATION MANOMETERS
Received Aug 4, 2021
Report 3012307300-2021-08062 · MDR key 12277180
Device
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE SURFACE OF THE DEVICES.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS#617147. NO PROBLEM OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. NO SAMPLES WERE RECEIVED BUT TWO PHOTOS WERE RECEIVED FOR EVALUATION. BASED ON THE IMAGES PROVIDED, IT WAS OBSERVED THAT THERE WERE INK STAINS INSIDE TUBE, THEREFORE FAILURE MODE CAN BE CONFIRMED. ROOT CAUSE CAN BE DETERMINED AS OPERATOR MISHANDLING USING PRODUCTION EQUIPMENT. A NOTIFICATION AWARENESS TO OPERATORS WERE ISSUED IN ORDER TO NOTIFY ALL PERSONNEL ABOUT ISSUE REPORTED WITH INK STAINS ON MANOMETER SURFACE, A QUALITY ALERT WAS IMPLEMENTED AT MANOMETER PRODUCTION LINE NOTIFYING ABOUT ISSUE REPORTED AND A POKA-YOKE IMPLEMENTATION IN FIXTURE AT MACHINE THAT WILL AVOID STARTING THE OPERATION WITHOUT ADDING A MANOMETER TUBE.