Kendall 33135T (UDI 10884521212596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521212596), received between Nov 4, 2020 and Jul 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (1 report).

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.

• MalfunctionJul 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT AN ISSUE OCCURRED IN ROOM (B)(6). THE PATIENT CAME IN AS A PRE-ADMIT BEFORE SURGERY. THEIR STANDARD PROCEDURE FOR SURGICAL PATIENTS IS TO PUT THEM ON THE DISPOSABLE LEADS, CONNECTED BY THE ADAPTERS ON EACH X2. THE PATIENT LEFT FROM THE CVU FOR SURGERY IN THE MORNING AND ARRIVED BACK TO THE ROOM ROUGHLY AROUND 2-3P. THEY DID NOT IMMEDIATELY EXPERIENCE ANY ISSUES WITH THE LEADS ON THE PATIENT. THE NIGHTSHIFT STATED THAT THE MONITOR ISSUES BEGAN AROUND 9P WHEN THE PATIENT WAS LAYING STILL IN BED, THE LEADS BEGAN TO READ HIGH RESPIRATORY RATES AND THE ECG LEADS WERE IN AND OUT OF SERVICE WITH THE MONITOR FREQUENTLY READING ASYSTOLE. THE NIGHT SHIFT NURSE ATTEMPTED NEW ELECTRODES ON THE PATIENT AT THIS TIME. THE NURSES PROCEEDED TO PUT THE PATIENT BACK ON THEIR OLD ECG LEADS AND THE ISSUES THEY WERE EXPERIENCING STOPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231710 ↗
• MalfunctionNov 4, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED THAT AFTER CHANGING ALL OF THE ADAPTERS, THEY ARE STILL HAVING A LOT OF PROBLEMS WITH THE TELEMETRY CABLES NOT PICKING UP OR GIVING BAD READINGS. A CRITICAL VASCULAR PATIENT WAS CODED BECAUSE THE CABLES LOOKED LIKE ASYSTOLE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE PATIENT HAD RECENTLY BEEN DIRECTLY ADMITTED TO THE ICU FROM THE OR AND WAS STILL INTUBATED AND SEDATED. THE PATIENT HAD POOR/WEAK PULSES AT BASELINE SO WHEN THE MONITOR READ ASYSTOLE AND IT BECAME DIFFICULT TO PALPATE A PULSE CPR WAS INITIATED BRIEFLY. THE PATIENT WAS NOT SHOCKED (THIS IS NOT A RECOMMENDED INTERVENTION FOR ASYSTOLE) AND NO MEDS WERE GIVEN BEFORE THEY REALIZED IT WAS FAULTY CABLES. NO FURTHER MEDICAL INTERVENTION OR FOLLOW UP CARE WAS REQUIRED. THE PATIENT WAS MADE CMO BY FAMILY THE NEXT DAY (UNRELATED TO THE MALFUNCTION) AND HAS SINCE PASSED AWAY. AFTER THE EVENT THE CABLES WERE SWITCHED OUT 2-3 TIMES ON THIS PATIENT BEFORE THEY FOUND A SET THAT WORKED. THEY WERE ALL THE SAME LOT NUMBER. ALL OF THE ADAPTERS WERE CHANGED INCASE THEY WERE CAUSING THE ISSUE HOWEVER, THE ISSUES HAVE CONTINUED.

  Patient problems: No Code Available

  MAUDE report 10788743 ↗