NA ORG-9100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 04931921103883), received between Mar 17, 2017 and Aug 6, 2026 — classified as 106 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (68 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Data Problem; Patient Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164497 ↗
• MalfunctionAug 3, 2026Communication or Transmission Problem; Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122460 ↗
• MalfunctionMay 15, 2026Failure to Read Input Signal; Communication or Transmission Problem

  THE NURSE REPORTED THAT ALL THEIR ZM TRANSMITTERS WERE IN COMM LOSS IN TICKET #252139. WHILE TROUBLESHOOTING THE ISSUE, TECHNICAL SUPPORT (TS) FOUND THAT THIS ORG HAD A LIT ERROR LIGHT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186714 ↗
• MalfunctionMar 4, 2026No Device Output; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED EXPERIENCING RANDOM COMM LOSS ERRORS WITH THIS MULTIPLE PATIENT RECEIVER (ORG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506529 ↗
• MalfunctionJan 20, 2026Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAS AN ERROR LIGHT. THE UNIT DOES NOT SEEM TO BE CONNECTED TO THE NETWORK AND CANNOT BE VIEWED ON THE HOST TABLE. BEDS 202-211 SHOW COMM-LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126652 ↗
• MalfunctionNov 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE NURSE REPORTED EXPERIENCING COMMUNICATION LOSS ERRORS INVOLVING FOUR ZM TRANSMITTERS MONITORED AT THE CENTRAL NURSE STATION (CNS) USING THE MULTIPLE PATIENT RECEIVER (ORG). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23652526 ↗
• MalfunctionOct 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THIS MULTIPLE PATIENT RECEIVER (ORG) WAS STUCK IN AN ERROR STATUS WHILE IN USE WITH PATIENTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380225 ↗
• MalfunctionOct 15, 2025Communication or Transmission Problem; Intermittent Communication Failure; Communication or Transmission Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ORG WAS CONSTANTLY IN INTERMITTENT COMM LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292990 ↗
• MalfunctionSep 9, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THIS ORG DISPLAYS A COMMUNICATION LOSS (COMM LOSS) INTERMITTENTLY ON THE ONLY 2 PATIENTS THAT WERE ADMITTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006614 ↗
• MalfunctionMay 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE ECG READINGS WERE FLUCTUATING AT THE CENTRAL NURSE STATION (CNS) (PU-681RA SN: (B)(6) WHEN TESTING A ZM TRANSMITTER, TELE 8, (MODEL & SN UNKNOWN) ON A SIMULATOR WITH THE MULTIPLE PATIENT RECEIVER (ORG-9100A, SN: (B)(6). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075556 ↗
• MalfunctionDec 11, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED RECEIVING AN EXCHANGE TELE AND THEY'RE STILL UNABLE TO SEE THE HEART RATE (HR). THE ISSUE APPEARS TO BE WITH THE RECEIVER CARD ON THE ORG. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903649 ↗
• MalfunctionDec 15, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT 5 TELEMETRY TRANSMITTERS WENT INTO COMM LOSS AT THE CENTRAL NURSES STATION (CNS). THE CUSTOMER FOUND THAT THE MULTIPLE PATIENT RECEIVER (ORG) HAD FAILED, CAUSING THE COMMUNICATION LOSS. NO PATIENTS WERE BEING MONITORED AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18337509 ↗
• MalfunctionSep 21, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER IT / IS REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS IN COMMUNICATION LOSS. THE ORG WAS REBOOTED, BUT THERE IS AN ERROR LIGHT ON THIS UNIT. THE WAS SENT IN FOR EVALUATION, BUT THE ISSUE COULD NOT BE DUPLICATED AND RETURNED TO THEM. HOWEVER, IT IS HAVING ISSUES AGAIN. THE UNIT CAME IN FOR EVALUATION AGAIN, BUT THE COMMUNICATION LOSS AND THE ERROR LIGHT ISSUE COULD NOT BE DUPLICATED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795773 ↗
• MalfunctionJul 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THERE ARE 4 TELEMETRY TRANSMITTERS IN COMMUNICATION LOSS WITH THE CENTRAL NURSE'S STATION (CNS). THE CUSTOMER LATER STATED THAT THE PATIENTS ON MULTIPLE PATIENT RECEIVER (ORG) SN (B)(4) WAS MOVED TO ANOTHER ORG, AND THEY CAME OUT OF COMMUNICATION LOSS AND ABLE TO MONITOR PATIENTS ON THEM. THE OTHER ORG SN (B)(4) WAS REBOOTED AND CAME OUT OF COMMUNICATION LOSS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006336 ↗
• MalfunctionJul 12, 2022Failure to Power Up; Power Problem; Failure to Power Up; Power Problem

  THE CUSTOMER REPORTED THAT AN NK TECH WAS RE-SETTING THE ORG UNIT AND WHEN THEY WENT TO TURN IT BACK ON, IT WOULD NOT POWER UP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986813 ↗
• MalfunctionApr 28, 2022Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT WHEN THEY ATTEMPT TO VIEW THE ARRYTHMIA RECALL (AR) DATA FOR THE TELEMETRY TRANSMITTERS, THEY DO NOT SEE DATA OR WAVEFORMS. THEY HAVE NOT HAD THE MULTIPLE PATIENT RECEIVER (ORG) SOFTWARE (SW) UPDATED AS OF YET. NIHON KOHDEN TECHNICAL SUPPORT (TS) LET THE CUSTOMER KNOW THIS IS A KNOWN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) AND THAT THEY NEED TO UPDATE THE SOFTWARE. TS INFORMED THEM OF THE RECALL AND PROVIDED THEM DOCUMENTATION REGARDING THIS AND THAT THEY CAN USE EVENT LIST AS AN ALTERNATIVE TO ARRHYTHMIA RECALL IN THE MEANTIME. THE NURSES COULD NOT VIEW AR FEATURE ON THE SCREEN OR PRINT FOR THE DOCTOR'S REVIEW FOR PATIENT DIAGNOSIS. ALTHOUGH THE DEVICE DOES OFFER OTHER MEANS TO BE ABLE TO VIEW THE DATA, THE CUSTOMER STATED THAT THIS IMPACTS PATIENT CARE FOR THE PURPOSE THEY ARE USING THAT DATA. REAL TIME PATIENT MONITORING NOT AFFECTED. THE CUSTOMER UPDATED THE SOFTWARE, AND THE ISSUE WAS RESOLVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14232578 ↗
• MalfunctionApr 14, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT ALL TRANSMITTERS ON THIS ORG ARE IN COMMUNICATION LOSS (COMM LOSS). THERE WAS NO PATIENT INJURY REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115841 ↗
• MalfunctionApr 13, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THIS MULTIPLE PATIENT RECEIVER (ORG) IS EXPERIENCING INTERMITTENT COMMUNICATION LOSS. THEIR CENTRAL NURSE'S STATION (CNS) DID NOT NOTIFY THEM OF THIS COMMUNICATION LOSS AND THEY ONLY FOUND OUT ABOUT IT BY REVIEWING THE ORG LOGS. THE CUSTOMER CHANGED THEIR PATIENTS FROM TRANSMITTERS TO BEDSIDE MONITORS IN ORDER TO GET THE COMMUNICATION LOSS ISSUE TO GO AWAY. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14094824 ↗
• MalfunctionMar 24, 2022Application Program Problem; Application Program Problem

  THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) WAS NOT WORKING AFTER TRYING TO SETUP HIQ VIEW FEATURE. THEY TRIED TO SETUP HIQ VIEW AND REBOOTED THE ORG AND NOW IT WILL NOT BOOT UP. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13881202 ↗
• MalfunctionMar 24, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THEY WERE EXPERIENCING SIGNAL LOSS OR INTERMITTENT SIGNAL LOSS AND WOULD APPRECIATE IT IF YOU COULD ASSIST WITH INFORMATION FOR THE ISSUE. TECH SUPPORT (TS) SUGGESTED THAT IT COULD BE AN ISSUE WITH THE MULTIPLE PATIENT RECEIVER (ORG) OR SOMETHING ALONG THE ANTENNA SYSTEM, BUT THE CUSTOMER DID NOT TROUBLESHOOT AS THEY STATED THAT THEY LOOKED AT ALL THAT ALREADY. THEY HAVE BEEN EXPERIENCING ISSUE SINCE (B)(6) 2021 AND WOULD LIKE TO GET SOMEONE OUT TO THE SITE TO RESOLVE THEIR ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13880388 ↗
• MalfunctionMar 23, 2022Output Problem; Intermittent Communication Failure; Output Problem; Intermittent Communication Failure

  THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) IS HAVING INTERMITTENT SIGNAL LOSS WITH CONNECTED DEVICES WHICH HAS BEEN HAPPENING THROUGH THE ENTIRE FACILITY EVER SINCE THE INSTALL HAD BEEN CONCLUDED. NO PATIENT HARM WAS REPORTED. THE BME REQUESTED AN ON-SITE SERVICE FROM NIHON KOHDEN TO DETERMINE THE CAUSE OF THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863833 ↗
• MalfunctionMar 10, 2022Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THEIR MULTIPLE PATIENT RECEIVER (ORG) IS EXPERIENCING CONSTANT COMMUNICATION LOSS. THE CUSTOMER DID NOT WANT TO TROUBLESHOOT AND WILL BE SENDING THIS UNIT IN FOR AN EXCHANGE. NO HARM OR INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13727040 ↗
• MalfunctionFeb 3, 2022Application Program Problem; Application Program Problem

  THE CUSTOMER REPORTED THAT THE ORG SHOWED SIGNAL LOSS AFTER A POWER "FLICKER" AT THE HOSPITAL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442861 ↗
• MalfunctionJan 20, 2022Loss of Power; Communication or Transmission Problem; Loss of Power; Communication or Transmission Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE FACILITY EXPERIENCED A POWER SURGE AND EVERYTHING CAME BACK UP EXCEPT THE MULTIPLE PATIENT RECEIVER (ORG'S) WHILE IN USE WITH PATIENTS. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN HAD THE BME REBOOT THE MULTIPLE PATIENT RECEIVER (ORG'S) AND WHEN THE BME DID THIS THE MULTIPLE PATIENT RECEIVER (ORG'S) STILL HAD THE LINK LIGHT OFF. THE BME SAID THAT THE SWITCH THAT THE MULTIPLE PATIENT RECEIVER (ORG'S) ARE CONNECTED TO IS AN (B)(4) SWITCH. NK TECHNICIAN RECOMMENDED TO THE BME TO CONTACT THE (B)(4) TECHNICAL SUPPORT SINCE THE ISSUE WITH THEIR SWITCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311338 ↗
• MalfunctionJan 17, 2022Signal Artifact/Noise; Output Problem; Signal Artifact/Noise; Output Problem

  THE BIOMEDICAL ENGINEER (BSM) REPORTED THAT THE MULTIPLE PATIENT RECEIVER (ORG) KEEPS GETTING A SIGNAL LOSS FROM ONE TRANSMITTER WHILE MONITORING A PATIENT IN THEIR ROOM. THE BME SWAPPED TO A DIFFERENT TRANSMITTER BUT THE ISSUE IS STILL THERE. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN ADVISED THE BME THAT IT IS LIKELY THE RECEIVER CARD IN THE ORG AND RECOMMENDED THAT THEY SEND IN THE ORG FOR REPAIR. CUSTOMER DECLINED RETURNING THE ORG TO NIHON KOHDEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266565 ↗