NA ZM-541PARecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04931921106617), received between May 13, 2016 and Feb 23, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THIS ZM TRANSMITTER WAS EXPERIENCING INTERMITTENT SIGNAL LOSS. THIS WAS THE ONLY UNIT BEHAVING THIS WAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414568 ↗
• MalfunctionMay 22, 2024Power Problem; Intermittent Loss of Power; Power Problem; Intermittent Loss of Power

  THE CUSTOMER REPORTED THAT THIS TRANSMITTER IS NOT WORKING PROPERLY. ACCORDING TO THE CUSTOMER, THE UNIT WILL ALMOST SHUT OFF ON ITS OWN SOMETIMES EVEN WITH NEW BATTERIES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377169 ↗
• MalfunctionOct 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE HR IS FLUCTUATING UP AND DOWN WHEN USING THIS DEVICE. THIS ISSUE REMAINS EVEN WHEN USING DIFFERENT LEADS AND ON A SIMULATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004651 ↗
• MalfunctionJul 28, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THEIR TRANSMITTER GAVE THEM A FALSE READING OF ASYSTOLE AFTER WHICH THEIR STAFF PANICKED AND GAVE THEIR PATIENT MEDICATION TO PREVENT AN INSINUATED HEART ATTACK. THEY ALSO SAID THAT THE PATIENT IS FINE BUT THE STAFF HAD TO GO THROUGH THESE STEPS UNNECESSARILY DUE TO THE FALSE READINGS.

  Patient problems: Unspecified Heart Problem

  MAUDE report 12236653 ↗
• MalfunctionJul 28, 2021Protective Measures Problem; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER GAVE THEM A FALSE READING OF ASYSTOLE AFTER WHICH THEIR STAFF PANICKED AND GAVE THE PATIENT MEDICATION TO PREVENT A HEART ATTACK, WHICH WAS NOT NEEDED BECAUSE THE PATIENT WAS NOT ACTUALLY IN ASYSTOLE. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 12236607 ↗
• MalfunctionJun 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE TELEMETRY TRANSMITTER WAS INTERMITTENTLY NOT READING RESPIRATION AND DOES NOT ALWAYS READ THE CORRECT VALUES. THE SIMULATOR IS SET FOR 30, AND IT WOULD READ 0 SOMETIMES AND VARYING NUMBERS AT OTHER TIMES. THIS WAS FOUND AT SET-UP AND WAS NOT BEING USED WITH THE CENTRAL NURSES STATION WHICH IS TYPICALLY A CONCOMITANT MEDICAL DEVICE. NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 10116978 ↗
• MalfunctionFeb 10, 2020Communication or Transmission Problem; Patient Device Interaction Problem; Intermittent Communication Failure; Communication or Transmission Problem; Patient Device Interaction Problem; Intermittent Communication Failure

  THE CUSTOMER REPORTED THAT ONE OF THEIR PATIENTS FELL WHILE A TRANSMITTER WAS ATTACHED TO THEM. THE CUSTOMER ALSO REPORTED THAT THEY COULD NOT CONFIRM THAT THIS HAPPENED BECAUSE OF THE TRANSMITTER.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9690760 ↗
• MalfunctionJul 25, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER THAT THE TRANSMITTER UNIT KEEPS INDICATING WRONG READINGS. WHEN THE CUSTOMER CHECK THE PATIENT READINGS ON THE CNS, THE READINGS DIFFER AND THE PATIENT'S VITALS SEEM FINE. NO CONSEQUENCE OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829370 ↗
• MalfunctionJun 27, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER IS GIVING LOW BLOOD PRESSURE READINGS AND IS OFF BY 20 POINTS, AND ALSO IS GIVING AN NIBP ERROR. NO PATIENT HARM REPORTED.

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

  MAUDE report 8741169 ↗
• MalfunctionMay 30, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE TRANSMITTER WILL NOT TRANSMIT SIGNAL CAUSING INTERRUPTION TO PATIENT MONITORING, BUT NOT FOR VERY LONG. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656309 ↗
• MalfunctionApr 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE NURSE REPORTED THAT THE TRANSMITTER DISPLAYED A DISTORTED HEART RATE WAVEFORM AT THE CENTRAL NURSE'S STATION (CNS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524924 ↗
• MalfunctionDec 20, 2018Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER BATTERIES MELTED THE REAR CASING OF THIS UNIT. NO CONSEQUENCE OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8187590 ↗
• MalfunctionJun 28, 2018Incorrect, Inadequate or Imprecise Result or Readings; Device Issue; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Issue; Output Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER IS GIVING OFF INACCURATE ECG READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7646156 ↗
• MalfunctionMar 22, 2018Overheating of Device; Device Issue; Misassembly by Users; Overheating of Device; Device Issue; Misassembly by Users

  THE CUSTOMER REPORTED THAT THE TRANSMITTER'S BATTERY CONTACTS HAD MELTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7364159 ↗
• MalfunctionMar 13, 2018Overheating of Device; Human Factors Issue; Temperature Problem; Misassembly by Users; Overheating of Device; Human Factors Issue; Temperature Problem; Misassembly by Users

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7335990 ↗
• MalfunctionSep 12, 2017Thermal Decomposition of Device; Overheating of Device; Temperature Problem; Thermal Decomposition of Device; Overheating of Device; Temperature Problem

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER'S BATTERY COVER WAS MELTED AND CLINICIANS NOTICED A BURNING SMELL. UPON VISUAL INSPECTION, THE BIOMEDICAL ENGINEER NOTICED THAT THE BATTERY CONTACTS WERE ALSO MELTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860464 ↗
• MalfunctionSep 12, 2017Incorrect Measurement; Invalid Sensing; Device Operational Issue; Incorrect Measurement; Invalid Sensing; Device Operational Issue

  THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER WAS GIVING INACCURATE NIBP READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6860461 ↗
• MalfunctionApr 19, 2017Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATS WHEN UNIT IS TURNED ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6506127 ↗
• MalfunctionApr 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE TRANSMITTER IS DISPLAYING DIFFERENT PARAMETERS THAN THE CENTRAL NURSES STATION (CNS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6500103 ↗
• MalfunctionMar 29, 2017Melted; Overheating of Device

  THE CUSTOMER REPORTS THAT THE TRANSMITTER GOT HOT AND MELTED THE BATTERY COMPARTMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443030 ↗
• MalfunctionMar 3, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER HEATED UP. THE BATTERIES WERE HOT AND THE INSULATION MELTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6376949 ↗
• OtherMay 13, 2016Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem

  THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED AND THE BATTERY CONTACTS MELTED. THERE WAS NO OTHER PHYSICAL DAMAGE AND NO FLUID INTRUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 5653885 ↗