RELIAMED JOJO THE JELLYFISH PEDIATRICCOMPRESS

Description of Event or Problem

VEGA FOUND THE MDR REPORT ON THE FDA WEBSITE: 1 MDR NO.:1423537-2016-00002. MDR REPORT CONTENTS: THE CUSTOMER CALLED IN FOR HER SON THAT USES THE PEDIATRIC NEBULIZER. WHEN USING THE UNIT AT SCHOOL SPARKS BEGAN TO FLY AND CAUSED THE ELECTRICITYAT THE SCHOOL TO GO OUT. NO ONE WAS INJURED. CUSTOMER HAS HAD THE UNIT ABOUT 1.5 TO 2 YEARS. MANUFACTURER NARRATIVE: (B)(4). THE DEVICE HISTORY RECORD FOR THE SERIAL NUMBER REPORTED WAS REVIEWED AND DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. MULTIPLE ATTEMPTS TO RETRIEVE THE SAMPLE TO AID IN DETERMINING A ROOT CAUSE WERE UNSUCCESSFUL. AS A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THE EXACT CAUSE OF THE FAILURE COULD NOT BE CONFIRMED. A REVIEW OF THE HISTORICAL TRENDING FOR THE PAST 12 MONTHS INDICATED THAT THIS IS THE FIRST REPORT RECEIVED OF THIS ISSUE. WE WILL CONTINUE TO MONITOR FOR ANY SIMILAR REPORTS. NG Q'TY: (B)(4).