NA ZM-521PARecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 04931921115084), received between Nov 24, 2016 and Sep 17, 2026 — classified as 1 injury, 78 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (61 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 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797169 ↗
• MalfunctionOct 8, 2024Signal Artifact/Noise; Signal Artifact/Noise

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER WAS PRODUCING A NOISY ECG SIGNAL WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20404088 ↗
• MalfunctionJun 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Communication or Transmission Problem; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Contamination /Decontamination Problem; Communication or Transmission Problem; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER HAD INACCURATE ECG READINGS AND WAS MISSING INFORMATION. THIS DEVICE WAS NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125729 ↗
• MalfunctionApr 27, 2022Overheating of Device; Temperature Problem; Appropriate Device Problem Term/Code Not Available; Overheating of Device; Temperature Problem; Appropriate Device Problem Term/Code Not Available

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE UNIT WAS WAITING TO CONNECT TO A PATIENT, AND THE STAFF NOTICED A SMALL AMOUNT OF "SMELL" COMING FROM THE UNIT. WHEN THEY OPENED THE DOOR, THEY FOUND THAT THE BATTERY HAD EXPANDED INSIDE THE UNIT. THE CUSTOMER HAD THROWN THE BATTERY AWAY BUT HAD TAKEN A PICTURE OF IT BEFORE DOING SO. TECH SUPPORT (TS) HAD REQUESTED A PICTURE OF THE BATTERY. THE DEVICE WAS NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14229796 ↗
• MalfunctionFeb 8, 2022Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TRANSMITTER GOT HOT AND SMOKED. THEY WERE NOT ABLE TO RECOVER THE BATTERIES THAT WERE CONNECTED TO THE TRANSMITTER SO THAT THEY COULD BE SENT IN FOR A PROPER INVESTIGATION. THEY STATED THAT THIS WAS REPORTED BY THE NURSES DURING THE NIGHT SHIFT. THIS WAS FOUND AT SET-UP AND NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13491727 ↗
• MalfunctionNov 18, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE A TELEMETRY TRANSMITTER THAT WAS GETTING HOT, AND THE CASE WAS CRACKED IN A COUPLE OF PLACES. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASSISTED THEM WITH REPLACING AND MONITORING ANOTHER TRANSMITTER. THIS WAS FOUND AT SET-UP, AND NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840680 ↗
• MalfunctionNov 18, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER WAS GETTING HOT, AND THE CASE WAS CRACKED IN A COUPLE PLACES. THIS ISSUE WAS DISCOVERED AT SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12840496 ↗
• MalfunctionJun 16, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS HEAT DAMAGE INSIDE THE BATTERY WELL OF THE TELEMETRY TRANSMITTER. THIS HAPPENED DESPITE EFFORTS TO PREVENT THE HEAT DAMAGE BY ENSURING FRESH BATTERIES AND NEW CONTACTS ARE USED AS OFTEN AS POSSIBLE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013557 ↗
• MalfunctionJun 16, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE WAS HEAT DAMAGE INSIDE THE BATTERY WELL OF THE TELEMETRY TRANSMITTER. THIS HAPPENED DESPITE EFFORTS TO PREVENT THE HEAT DAMAGE BY ENSURING FRESH BATTERIES AND NEW CONTACTS ARE USED AS OFTEN AS POSSIBLE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013362 ↗
• MalfunctionApr 15, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER IS OVERHEATING DURING USE ON PATIENT, NO PATIENT HARM OCCURRED, THE UNIT JUST GOT WARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673280 ↗
• MalfunctionApr 15, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER IS OVERHEATING DURING USE ON PATIENT, NO PATIENT HARM OCCURRED, THE UNIT JUST GOT WARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672329 ↗
• MalfunctionMar 31, 2021Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THIS TRANSMITTER IS OVERHEATING. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596982 ↗
• MalfunctionMar 31, 2021Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THIS TRANSMITTER IS OVERHEATING. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596863 ↗
• MalfunctionMar 7, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER WAS NOT ON A PATIENT AT THE TIME THAT THIS UNIT OVERHEATED. THEY ARE NOT SURE WHAT CAUSED THIS TO OVERHEAT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THEM FOR MORE DETAILS AND WAS TOLD THAT THE UNIT WAS ABOUT TO BE USED AND FOUND THAT BATTERY COMPARTMENT AREA WAS ALREADY MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429557 ↗
• MalfunctionMar 7, 2021Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER WAS NOT ON A PATIENT AT THE TIME THAT THIS UNIT OVERHEATED. THEY ARE NOT SURE WHAT CAUSED THIS TO OVERHEAT. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) ASKED THEM FOR MORE DETAILS AND WAS TOLD THAT THE UNIT WAS ABOUT TO BE USED AND FOUND THAT BATTERY COMPARTMENT AREA WAS ALREADY MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429546 ↗
• MalfunctionDec 23, 2020Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER WAS SHOWING INCORRECT HEART RATE (HR) READINGS. THEY ALSO REPORTED THAT THIS TRANSMITTER WAS SHOWING DIFFERENT READINGS THAN THE CENTRAL NURSE'S STATION (CNS). ADDITIONALLY, THEY REPORTED THAT THE DEVICE HAD PHYSICAL DAMAGE TO THE CASE AND THAT A BUTTON WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068364 ↗
• MalfunctionSep 3, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE BATTERY CONTACTS ON THE TRANSMITTER WERE SMOKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10491904 ↗
• MalfunctionJul 1, 2020Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT THEIR TRANSMITTER INTERMITTENTLY SHUTS OFF AND ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10219656 ↗
• MalfunctionFeb 26, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED, CAUSING HEAT DAMAGE TO THE BATTERY COMPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9753086 ↗
• MalfunctionFeb 26, 2020Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED, CAUSING HEAT DAMAGE TO THE BATTERY COMPARTMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753077 ↗
• MalfunctionJan 17, 2020Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation

  THE CUSTOMER REPORTED THAT THE PATIENT CLAIMED THAT THE TRANSMITTER DELIVERED HER A SHOCK. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9604436 ↗
• MalfunctionDec 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED CAUSING THE BATTERY CONTACTS TO MELT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9485179 ↗
• MalfunctionOct 18, 2019Overheating of Device; Overheating of Device

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER STARTED MAKING NOISE AND THEN BECAME EXTREMELY HOT AND INDICATED SIGNAL LOSS ON THE SCREEN. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9210988 ↗
• MalfunctionOct 7, 2019Display or Visual Feedback Problem; Overheating of Device; Display or Visual Feedback Problem; Overheating of Device

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER HAD BATTERY HEAT DAMAGE AND THE METAL SPRINGS INSIDE THE BATTERY COMPARTMENT WERE MELTED FROM THE HEAT. THIS TRANSMITTER ALSO HAD A WHITE LCD SCREEN. THE DEVICE WILL BE RETURNED FOR EVALUATION. THIS DEVICE WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9162082 ↗
• MalfunctionOct 7, 2019Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TELEMETRY TRANSMITTER HAD BATTERY HEAT DAMAGE AND THE METAL SPRINGS INSIDE THE BATTERY COMPARTMENT WERE MELTED FROM THE HEAT. THE DEVICE WILL BE RETURNED FOR EVALUATION. THIS DEVICE WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9162077 ↗