NA ZM-531PARecalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 04931921115107), received between Mar 3, 2017 and Sep 25, 2026 — classified as 1 death, 4 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Output Problem” (50 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 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  The Biomedical Engineer (Biomed) reported that the ZM Transmitter was experiencing intermittent Signal Loss at the Central Nurse's Station (CNS), losing the signal for a few seconds to minutes at a time. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900429 ↗
• MalfunctionSep 25, 2026Unable to Obtain Readings; Failure to Read Input Signal; Communication or Transmission Problem

  The Biomedical Engineer (Biomed) reported that the ZM Transmitter was experiencing intermittent signal dropouts and displaying Signal Loss at the Central Nurse's Station (CNS). No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900105 ↗
• MalfunctionSep 23, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873524 ↗
• MalfunctionSep 14, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754096 ↗
• MalfunctionSep 11, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736212 ↗
• InjurySep 4, 2026Unable to Obtain Readings; Communication or Transmission Problem

  The Biomedical Engineer (Biomed) reported that on (b)(6) 2026, during a patient transport, the ZM Transmitter went into signal loss, and the Biomed believes (but cannot 100% confirm) there was a break in data at the Central Nurse's Station (CNS) during the period of Signal Loss. The signal loss failed to alert staff of the patient's condition which ultimately led to the patient experiencing a seizure.

  Patient problems: Convulsion/Seizure

  MAUDE report 50614853 ↗
• MalfunctionSep 4, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611801 ↗
• MalfunctionAug 11, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208234 ↗
• MalfunctionAug 7, 2026Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  The Biomedical Engineer (Biomed) reported that the ZM Transmitter would intermittently drop its connection with the CNS. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181817 ↗
• MalfunctionAug 5, 2026Unable to Obtain Readings; Output Problem

  The Biomedical Engineer (Biomed) reported that the ECG waveforms on the ZM Transmitter would display briefly and then disappear, similar to when the leads are disconnected. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148272 ↗
• MalfunctionJun 25, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) STATED THAT THE STAFF REPORTED MULTIPLE TIMES THAT THE ZM TRANSMITTER WOULD NOT ALWAYS GIVE CORRECT ECG READINGS. THE DEVICE WAS ALSO CRACKED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627420 ↗
• MalfunctionMay 26, 2026Failure to Read Input Signal; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER WOULD NOT MAINTAIN A SIGNAL. THE ECG RHYTHM WOULD COME IN FOR A FEW MINUTES THEN INTERMITTENTLY GO BLANK. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285617 ↗
• MalfunctionMay 22, 2026Display or Visual Feedback Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE CUSTOMER REPORTED THAT LEAD 1 WAVEFORM IS INVERTED ON THIS TRANSMITTER. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258936 ↗
• MalfunctionMay 12, 2026Overheating of Device; Smoking; Temperature Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER HAD A BURNING BATTERY CONNECTOR. ACCORDING TO THE TELEMONITOR TECH, SMOKE CAME OUT AND THE BATTERY TERMINAL WAS MELTED. THE BIOMED STATED HE COULD SEE THAT THE BATTERY TERMINAL WAS BURNED OR MELTED. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155931 ↗
• MalfunctionMay 5, 2026Application Program Problem; Power Problem; Complete Loss of Power; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE ZM TRANSMITTER WOULD POWER OFF AND ENTER A BOOT LOOP CYCLE AFTER ABOUT 20 MINUTES OF OPERATION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086547 ↗
• MalfunctionApr 23, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS ZM TRANSMITTER DISPLAYS NORMAL ECG DATA ON THE UNIT ITSELF; HOWEVER, WHEN BEING MONITORED ON ANY RECEIVER CARD, THE CENTRAL NURSE'S STATION (CNS) HAS A JAGGED WAVEFORM. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966542 ↗
• MalfunctionApr 16, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSING STAFF OBSERVED A ZM TELEMETRY TRANSMITTER DISPLAYING APPROXIMATELY DOUBLE THE PATIENT'S ACTUAL HEART RATE COMPARED TO MANUAL CHECKS. THE NURSES REPLACED THE ZM, WHICH RESOLVED THE ISSUE. THEY LATER WENT TO DEPARTMENT 6W AND TESTED THE TRANSMITTER USING A SIMULATOR BUT WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER, HE DID OBSERVE SIGNIFICANT ARTIFACT WHILE USING THE TRANSMITTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901557 ↗
• MalfunctionApr 16, 2026Signal Artifact/Noise; Display or Visual Feedback Problem; Image Display Error/Artifact; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS EXPERIENCING ARTIFACTS THAT LOOKED SIMILAR TO WHEN A KID COLORS IN A COLORING BOOK. THIS WAS SPECIFICALLY ON LEADS VA AND VB. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899091 ↗
• MalfunctionApr 9, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER GAVE INCORRECT HEART RATE (HR) WAVEFORMS. WHEN HE TESTED THE ZM DEVICE ON A SIMULATOR THAT WAS SET TO 60 BPM, THE DEVICE SHOWED 30 TO 80 BPM. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832014 ↗
• MalfunctionMar 31, 2026Battery Problem; Communication or Transmission Problem; Battery Problem: Low Impedance

  THE CUSTOMER REPORTED THAT THIS ZM TRANSMITTER LOSES SIGNAL AND SAYS BATTERIES ARE LOW, EVEN WHEN KNOWN-GOOD BATTERIES ARE INSTALLED. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746826 ↗
• MalfunctionMar 19, 2026No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE ECG WAVEFORMS FROM THIS TRANSMITTER DISPLAY CORRECTLY; HOWEVER, THEY DISAPPEAR AT THE CENTRAL NURSE'S STATION (CNS) AFTER APPROXIMATELY 2 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640462 ↗
• MalfunctionMar 11, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT WHEN GOING INTO ZM VIEW THE ZM TELE SHOWS THE PATIENT DATA FROM ANOTHER ZM TELE INSTEAD OF THE BEDSIDE MONITOR WITH THE CORRECT PATIENT. REUBEN CALLED IN STATING HE HAS 2 ZM TELES DISPLAYING THE SAME PATIENT DATA FROM THE CENTRAL NURSE'S STATION (CNS). HE STATED HE ALREADY TRIED DISCHARGING THE PATIENTS AND THEN READMITTING THE PATIENTS BUT THAT DID NOT RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574616 ↗
• MalfunctionFeb 11, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS DISPLAYING THE ECG WAVEFORMS ON THE DEVICE ITSELF, BUT NOT AT THE CENTRAL NURSE STATION (CNS). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313486 ↗
• MalfunctionFeb 10, 2026Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS EXPERIENCING INTERMITTENT DROPOUTS DURING PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309980 ↗
• MalfunctionFeb 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ZM TRANSMITTER WAS NOT TAKING ECG READINGS ON ALL THE LEADS. THEY WERE TRYING TO VIEW 4 LEADS ON A SIMULATOR BUT ONLY LEAD II WAS SEEN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292504 ↗