PORTEX HYPERINFLATION RESUSCITATION MANOMETERS
Received May 2, 2023
Report 3012307300-2023-04907 · MDR key 16857620
Device
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER TEXT: E4: CUSTOMER REPORTED TO FDA IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. PICTURES WERE RECEIVED IN COMPLAINT INVESTIGATION, DURING REVIEW OF THE IMAGES INK STAINS INSIDE TUBE WERE OBSERVED. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE OPERATOR MISHANDLING USING PRODUCTION EQUIPMENT. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: A NOTIFICATION AWARENESS TO OPERATORS WERE ISSUED IN ORDER TO NOTIFY ALL PERSONNEL ABOUT ISSUE REPORTED WITH INK STAINS ON MANOMETER SURFACE.
Description of Event or Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE SURFACE. NO PATIENT INJURY WAS REPORTED.