Kendall 33527TRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521212527), received between Jan 14, 2021 and Feb 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021Break; Overheating of Device; Break; Overheating of Device

  THE CUSTOMER REPORTED THE ADAPTER IS BREAKING AND THE TELEBOX THAT IS USING THE ADAPTERS GETS HOT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307707 ↗
• MalfunctionJan 14, 2021Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE ADAPTER "MELTED" INTO THE DATASCOPE PANORAMA TELEBOX. THE TELEBOX WAS TOO HOT TO TOUCH, SO PLIERS WERE USED TO EXTRACT THE ADAPTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TELEBOX WAS USED DURING A NORMAL EKG MONITORING PROCEDURE. THERE WAS NO PROBLEM SEEING IT OR READING THE DISPLAY, BUT IT DID CAUSE CENTRAL TELE TO GO CHECK ON IT DUE TO IRREGULAR RHYTHM. THERE WAS NO INJURY RELATED TO THIS ISSUE. IT WAS ALSO STATED THAT IT IS NOT KNOWN WHICH DEVICE GOT HOT FIRST, THE TELEBOX OR THE ADAPTER. THE BOX WAS SO HOT THAT THEY HAD TO PULL THE ADAPTER OUT OF THE BOX. THEY DO NOT KNOW THE REASON WHY IT OVERHEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171892 ↗