PORTEX
Received Sep 19, 2022 · Event occurred Feb 12, 2020
Report 3012307300-2022-19607 · MDR key 15445578
Device
Generic name
Meter, Airway Pressure (inspiratory Force)
Manufacturer
Smiths Medical Asd, Inc.Model number
55-6060Catalog number
55-6060
Lot number
3898024
Product problems
- Operating System Becomes Nonfunctional
- Operating System Becomes Nonfunctional
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE FUNCTIONAL TESTE FAILED. AFTER TESTING WITH POSITIVE AND NEGATIVE PRESSURE USING A SMALL SYRINGE, THE GAUGE POINTER CANNOT RETURN TO ZERO AND STOPS AT JUST OUTSIDE THE EDGE OF THE BLACK SQUARE. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. NO PROBLEM WAS FOUND. ROOT CAUSE CANNOT BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE FACT THE SAMPLE WAS TESTED AND SUCCESSFULLY PASSED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147.