Prefense EDNS-9001Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00851725007023), received between Jan 11, 2017 and Mar 16, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Output Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Device Alarm System; Protective Measures Problem; Device Alarm System; Protective Measures Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE O2 ALARMS WERE NOT WORKING ON THE PREFENSE SYSTEM. WHEN TRYING TO REBOOT THE SYSTEM, THEY RECEIVED A BOOT UP ERROR AND THE SYSTEM WOULD NOT FULLY BOOT BACK UP. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561116 ↗
• MalfunctionMar 9, 2023No Audible Alarm; Protective Measures Problem; No Audible Alarm; Protective Measures Problem

  THE CUSTOMER REPORTED THAT THERE'S NO SOUND COMING OUT OF THIS UNIT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518346 ↗
• MalfunctionJan 7, 2022Application Program Problem; Unintended Application Program Shut Down; Application Program Problem; Unintended Application Program Shut Down

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PREFENSE SYSTEM WAS SHUTTING DOWN. THEY WERE ABLE TO GET THE DEVICE BACK ON LAST NIGHT, BUT THEY HAVE NOTICED THAT THE POWER LIGHT IS FLASHING, AND THE UNIT IS NOT DISPLAYING CONTENT. TECH SUPPORT (TS) INFORMED THEM THAT THIS WAS AN END OF LIFE DEVICE. THE CUSTOMER LATER TOLD TECH SUPPORT STATED THAT THEY WILL BE REPLACING THE MOTHERBOARD ON THIS DEVICE. THIS WAS NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13198586 ↗
• MalfunctionSep 24, 2021Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR PREFENSE MONITOR IS NOT ANY DISPLAYING ANY ETCO2 DATA. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530618 ↗
• MalfunctionSep 24, 2021Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR PREFENSE MONITOR IS NOT ANY DISPLAYING ANY ETCO2 DATA. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530617 ↗
• MalfunctionSep 8, 2021Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

  THE CUSTOMER REPORTED THAT THE PREFENSE MONITOR'S DISPLAY WAS BLUE AND DISPLAYED A MESSAGE THAT STATED, THE UNIT WILL SHUT DOWN IN ORDER TO NOT DAMAGE THE UNIT. WHEN THE CUSTOMER ATTEMPTED TO POWER IT BACK ON, THE UNIT WOULD NOT POWER ON. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443803 ↗
• MalfunctionMar 20, 2021Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PRETENSE MONITOR FROZE. REBOOTING THE DEVICE TWO TIMES DID NOT RESOLVE THE ISSUE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536728 ↗
• MalfunctionMar 10, 2021Output Problem; Data Problem; Output Problem; Data Problem

  THE CUSTOMER REPORTED THAT THE NIBP WAS NOT SAVING IN THE VITAL SIGNS REVIEW WHICH WAS AN ISSUE WITH HISTORICAL DATA SAVING FOR THE NIBP ON THE PREFENSE TELEMETRY MONITORING SYSTEM. NIHON KOHDEN TECHNICAL SUPPORT (TECH SUPPORT) VERIFIED THAT THE REAL TIME ALARMS ARE WORKING NORMALLY AND THAT THE NIBP MEASUREMENT POP UP ON THE ALL BEDS SCREEN. HOWEVER, WHEN THEY GO TO VITAL SIGNS REVIEW, ITS NOT THERE. THIS IS DUE TO THE MULTIPLE PATIENT RECEIVER (ORG) ISSUE WHICH AFFECTS THE TELEMETRY TRANSMITTER MONITORING. THIS DEVICE IS END OF LIFE. ON 02/09/2021, ADDITIONAL INFORMATION WAS PROVIDED TO US THAT STATED THAT THE CUSTOMER HAD ADDITIONAL ISSUES WHERE THE UNIT WAS NOT STORING ANY (HISTORICAL) INFORMATION. AFTER THE REBOOT, THE ISSUE WAS CORRECTED, EXCEPT THE DEVICE WAS STILL NOT SAVING THE NIBP. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11458003 ↗
• MalfunctionFeb 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT ON THE PREFENSE (EDNS) THERE WERE DISCREPANCIES IN THE HISTORICAL VITAL SIGNS PRINTED OUT FOR THE SAME PATIENT FOR THE SAME TIME FRAME WHEN PRINTED IN INTERVALS. THE PRINT OUT AT 10 AM IS DIFFERENT FROM THE PRINT OUT AT 6PM FOR THE PATIENT VITALS FOR THE SAME TIME FRAME. THIS DEVICE IS AT END OF LIFE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290045 ↗
• MalfunctionMay 8, 2020Power Problem; Unintended Application Program Shut Down; Power Problem; Unintended Application Program Shut Down

  THE CUSTOMER REPORTED THAT THE PREFENSE MONITORING SYSTEM WENT DOWN WHILE MONITORING PATIENTS. THEY TRIED SWAPPING THE HARD DISC DRIVES (HDDS) FROM ANOTHER DEVICE. UPON REBOOT, THEY RECEIVED A WINDOWS ERROR MESSAGE. NO PATIENT HARM REPORTED.

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

  MAUDE report 10039441 ↗
• MalfunctionMay 7, 2020Power Problem; Unintended Application Program Shut Down; Power Problem; Unintended Application Program Shut Down

  THE CUSTOMER STATED THAT THE PREFENSE MONITORING SYSTEM SHOWED NO SIGNS OF ACTIVITY. THE LED ON THE DISPLAY DID NOT LIGHT UP. THE CALLED WAS UNINTERESTED IN TROUBLESHOOTING THE ISSUE FURTHER AND DECIDED TO REPLACE THE PREFENSE WITH ANOTHER DEVICE. THE CUSTOMER WAS TOLD THAT WE NO LONGER SUPPORT THE PREFENSE AND CANNOT BE REPAIRED. THIS UNIT IS USED TO MONITOR TELEMETRY TRANSMITTERS. NO PATIENT HARM REPORTED.

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

  MAUDE report 10034205 ↗
• MalfunctionFeb 21, 2020No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE NURSE REPORTED THAT THE PREFENSE DISPLAY TURNED OFF WHILE MONITORING TELEMETRY TRANSMITTERS. NIHON KOHDEN QA CONTACTED THE BIOMEDICAL ENGINEER AND WAS TOLD THAT THEY RESOLVED THE ISSUE BY REPLACING A BAD SPLITTER FOR THE REMOTE MONITORING DISPLAYS. NO PATIENT HARM REPORTED.

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

  MAUDE report 9742256 ↗
• MalfunctionJan 27, 2017No Display/Image; Device Inoperable; No Display/Image

  THE CUSTOMER REPORTS THAT THE SCREEN ON THE PREFENSE DOES NOT WORK WHILE IN PATIENT USE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6284947 ↗
• MalfunctionJan 11, 2017Smoking; Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTS THAT THE MONITOR/SCREEN FOR THE PREFENSE STARTED TO SMOKE. CUSTOMER SHUT THE UNIT DOWN AND DISCONNECTED THE MONITOR FROM THE MAIN UNIT. NO PATIENT HARM WAS REPORTED. ONE PATIENT WAS BEING MONITORED ON THE DEVICE, ADDITIONALLY; THEY WERE ALSO MONITORED ON TWO OTHER NIHON KOHDEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6244711 ↗