GN ReSound 21790300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708296214440), received between Mar 22, 2023 and Jul 28, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2023Overheating of Device; Overheating of Device

  ESTIMATED DATE OF INCIDENT 01JUN2023. ON (B)(6) 2023 IT WAS REPORTED: CHARGER MELTED THAT CAUGHT ON FIRE. PATIENT WAS NOT INJURED. PATIENT WAS USING STOCK CORDS AND CHARGER PROVIDED BY RESOUND. PATIENT DOES NOT BELIEVE CORD OR CHARGER WERE DAMAGED PRIOR. CHARGER WAS PLUGGED IN APPROXIMATELY 2 HOURS WHEN PATIENT SMELLED BURNING. DEVICE IS OUT OF WARRANTY. FURTHER FOLLOW RECEIVED: ON FOLLOW UP OF THE ALLEGATION OF FIRE AND WHAT THE USER HAS EXPERIENCED, IT HAS BEEN NOW CLARIFIED THAT THERE WAS ONLY SMELL OF BURNING PLASTIC AND PORT MELTING. NO CONFIRMATION OF ACTUAL FIRE. USER, 60 YEARS OLD FEMALE. DATE OF INCIDENT IS (B)(6) 2023. DEVICE WAS BOUGHT 24NOV2021 AND COVERED BY WARRANTY UNTIL 24DEC2024. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412252 ↗
• MalfunctionJul 7, 2023Overheating of Device; Overheating of Device

  IT HAS BEEN REPORTED THAT ON (B)(6) 2023 (ESTIMATED DATE)- CHARGER LIT UP, WENT DEAD, GOT HOT AND SMELLED LIKE FIRE. IT DOES NOT APPEAR THAT ORIGINAL ACCESSORIES HAVE BEEN USED. NO FURTHER FOLLOW UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278355 ↗
• MalfunctionMar 30, 2023Overheating of Device; Overheating of Device

  IN (B)(6) 2023 (BEST ESTIMATE), END USER REPORTED THAT THE CHARGER OUTLET WAS OVERHEATING AND HAD STARTED SMOKING AND CAUGHT FIRE. THERE WERE NO ALLEGATIONS OF HARM TO THE END USER NOR DID THEY SEEK ANY MEDICAL INTERVENTION. IT IS UNKNOWN IF ORIGINAL EQUIPMENT WAS USED. THREE SEPARATE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION BUT WAS UNSUCCESSFUL. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644041 ↗
• MalfunctionMar 22, 2023Overheating of Device; Overheating of Device

  ON AN UNKNOWN DATE IN FEBRUARY 2023 (BEST ESTIMATE), A PATIENT REPORTED TO THEIR HCP THAT THE CHARGER IS OVERHEATING - UNCOMFORTABLY HOT TO THE TOUCH. HCP ADVISED TO UNPLUG THE CHARGER. A REPLACEMENT CHARGER WAS SENT. NO ALLEGATION OF HARM OR DAMAGE TO PERSON OR PROPERTY. (B)(6) 2023 ORIGINAL EQUIPMENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590710 ↗