NA ORG-9110ARecalls & reported problems

Summary

The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 04931921103906), received between Feb 10, 2017 and Sep 17, 2026 — classified as 272 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (232 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809795 ↗
• MalfunctionSep 16, 2026Data Problem; Patient Data Problem

  The Biomedical Engineer (Biomed) reported that at the Central Nurse's Station (CNS), the ZM tele was swapping between 3 different patient's names. Those were the last 3 patients admitted on this tele before the current patient was admitted. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790603 ↗
• MalfunctionSep 4, 2026Unable to Obtain Readings; Communication or Transmission Problem; Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50620255 ↗
• MalfunctionSep 2, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572337 ↗
• MalfunctionSep 2, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569943 ↗
• MalfunctionAug 27, 2026Unable to Obtain Readings; Communication or Transmission Problem; Output Problem

  The IT department reported that the Multiple Patient Receiver (ORG) could not be seen at the Central Nurse's Station (CNS) and had a blinking error light. They were unable to add any beds to the receiver cards. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484639 ↗
• MalfunctionAug 26, 2026Unable to Obtain Readings; Communication or Transmission Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457234 ↗
• MalfunctionAug 26, 2026Unable to Obtain Readings; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457028 ↗
• MalfunctionAug 13, 2026Unable to Obtain Readings; Communication or Transmission Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237564 ↗
• MalfunctionAug 12, 2026Unable to Obtain Readings; Communication or Transmission Problem

  The Biomedical Engineer (Biomed) reported that the telemetry devices 1-6 displayed a "Comm Loss" error message. 2 Multiple Patient Receivers (ORGs) were associated with the telemetry devices, and this ORG had a lit error light. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223773 ↗
• MalfunctionAug 5, 2026Unable to Obtain Readings; Communication or Transmission Problem; Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147425 ↗
• MalfunctionAug 4, 2026Unable to Obtain Readings; Communication or Transmission Problem

  The Biomedical Engineer (Biomed) reported that the Multiple Patient Receiver (ORG) was showing Comm Loss for all 8 receiver cards. Each receiver card successively going into Comm Loss throughout the day until they were all in Comm Loss. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131457 ↗
• MalfunctionAug 3, 2026Unable to Obtain Readings; Communication or Transmission Problem; Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123398 ↗
• MalfunctionAug 3, 2026Unable to Obtain Readings; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122864 ↗
• MalfunctionJul 17, 2026Unable to Obtain Readings; Communication or Transmission Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25858175 ↗
• MalfunctionJul 17, 2026Unable to Obtain Readings; Communication or Transmission Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25857604 ↗
• MalfunctionJul 1, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT 8 TELEMETRY UNITS ARE IN COMM-LOSS. HE NOTES THE MULTIPLE PATIENT RECEIVER (ORG) HAS 3 GREEN LIGHTS, BUT THE ERROR LIGHT IS FLASHING. TECH SUPPORT (TS) HAD THEM POWER CYCLE THE ORG FOR 5 MINUTES, AND THE ISSUE PERSISTED. TS HAD THEM CHECK THE PORT ON THE SWITCH AND HE REPORTED A SOLID GREEN LIGHT ON THE PORT. TS HAD HIM TRY ANOTHER PORT, AND HE CONFIRMED ALL LIGHTS ARE GREEN BETWEEN THE PORT AND ORG, BUT THE ERROR LIGHT IS STILL BLINKING GREEN. TS THEN CONFIRMED THE CAUSE OF THE ISSUE TO BE THE ORG AFTER TROUBLESHOOTING AND RECOMMENDED TO SEND THE UNIT IN FOR REPAIR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25682585 ↗
• MalfunctionJul 1, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS BEEN DETERMINED TO BE DEFECTIVE ACCORDING TO NK REPS THAT ARE ONSITE WORKING ON THEIR COMMUNICATION LOSS AND SIGNAL LOSS ISSUES. HE SAID THAT HE WOULD LIKE TO SEND IT IN FOR AN EVALUATION. THEY WERE GETTING INTERMITTENT COMMUNICATION LOSS AND SIGNAL LOSS EVEN AFTER REPLACING THE RECEIVER CARDS IN THE UNIT. THEY HAVE SINCE REPLACED THE ORG ITSELF WITH A SPARE AND SINCE THEN THE ISSUE HAS NOT PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681800 ↗
• MalfunctionJun 22, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THEY HAVE THIS MULTIPLE PATIENT RECEIVER (ORG) GOING INTO COMM LOSS FOR ABOUT 30 SECONDS AND THEN COMES BACK. CUSTOMER STATES THAT THIS SEEMS RANDOM, APPROXIMATELY EVERY 30MIN OR SO. THIS IS AFFECTING ONLY ONE ORG, BED-ID'S TELE20- TELE26. ALL 7 BEDS ARE GOING INTO COMM LOSS AT THE SAME TIME (THIS ORG IS ONLY SETUP FOR 7 BEDS, THERE IS A FREE, UNUSED CHANNEL THAT IS NOT BEING MONITORED). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586002 ↗
• MalfunctionJun 4, 2026Wireless Communication Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) DISPLAYED AN INTERMITTENT COMMUNICATION LOSS (COMM LOSS) ERROR MESSAGE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390929 ↗
• MalfunctionMay 21, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD A LIT ERROR LIGHT AND DROPPED THE SIGNAL TO THE ZM TRANSMITTERS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25249775 ↗
• MalfunctionMay 18, 2026Communication or Transmission Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT A ZM TRANSMITTER WAS INTERMITTENTLY EXPERIENCING SIGNAL LOSS AND, WHEN CONNECTED, WAS DISPLAYING ARTIFACTS AND SPORADIC RESPIRATION RATE (RR) WAVEFORMS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201795 ↗
• MalfunctionApr 27, 2026Unable to Obtain Readings; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REQUESTED NK ONSITE SUPPORT SERVICES FOR INTERMITTENT COMMUNICATION LOSS FOR SEVERAL TELEMETRY DEVICES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998418 ↗
• MalfunctionApr 27, 2026Unable to Obtain Readings; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REQUESTED NK ONSITE SUPPORT SERVICES FOR INTERMITTENT COMMUNICATION LOSS FOR SEVERAL TELEMETRY DEVICES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998130 ↗
• MalfunctionApr 13, 2026Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS DISPLAYING COMMUNICATION LOSS INTERMITTENTLY FOR ALL DEVICES CONNECTED TO IT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867117 ↗