SIMPLYGO

Description of Event or Problem

A SIMPLYGO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER ALLEGING THE DEVICE WOULD TURN OFF. DURING EVALUATION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE THERMAL DAMAGE TO THE PCA (PRINTED CIRCUIT ASSEMBLY). THE PCA WAS BURNED AND IN NEED OF REPLACEMENT. THE DEVICE WAS ALSO FOUND TO HAVE LOW OXYGEN, AND THE SIEVES WERE DEFECTIVE AND NEEDED REPLACEMENT. THE TUBING KIT WAS CONTAMINATED. THE COMPRESSOR WAS IN NEED OF REPLACEMENT, AND THE INLET FILTER WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE DEVICE WAS REPAIRED AND PASSED A PERFORMANCE TEST. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.

Additional Manufacturer Narrative

H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.