Life Scope PT BSM-1773Recalls & reported problems
Nihon Kohden Corporation · Transport Monitor, NK SpO2 · Class 2
All models of Life Scope PT (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04931921111956), received between May 30, 2018 and Apr 11, 2026 — classified as 8 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Compatibility Problem” (8 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.
Reports received per month
Most reported problems
Device problems
- Compatibility Problem8
- Device Operational Issue8
- Thermal Decomposition of Device8
- Communication or Transmission Problem2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Output Problem2
- Power Problem2
- Battery Problem1
Patient problems
- Injury8
- No Clinical Signs, Symptoms or Conditions8
- Patient Problem/Medical Problem8
- Pressure Sore/Ulcer8
- Abrasion7
- No Consequences Or Impact To Patient2
- Bruise/Contusion1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Electrical /Electronic Property Problem; Battery Problem
THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) DOES NOT RECOGNIZE THE BATTERY AND THE UNIT DISPLAYS A BATTERY ALARM. IT IS UNKNOWNN WHETHER THE UNIT WAS IN PATIENT USE AT THE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846030 ↗MalfunctionSep 9, 2025Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE BEDSIDE MONITOR (BSM) WAS NOT TAKING ECG READINGS. NOT IN PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003832 ↗MalfunctionNov 10, 2023No Device Output; Output Problem; No Device Output; Output Problem
THE NURSE REPORTED THAT THEY ARE HAVING INTERMITTENT NIBP ISSUES, AND ON (B)(6) 2023 THEY REPORTED THEY WERE UNABLE TO OBTAIN NIBP. THE PATIENT ALSO EXPIRED. QA HAS ASKED FOR THE SERIAL NUMBER OF THE BSM-1773A AND ADDITIONAL DEVICE INFORMATION, BUT THE CUSTOMER HAS BEEN UNRESPONSIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108830 ↗MalfunctionJun 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Patient Data Problem; Incorrect, Inadequate or Imprecise Result or Readings; Patient Data Problem
THE NURSE REPORTED THAT DURING A SURGERY THERE WAS A DISCREPANCY BETWEEN THE BEDSIDE MONITOR (BSM) AND THEIR ELECTRONIC MEDICAL RECORD (EMR). THE NURSE REPORTED THAT THE DISCREPANCY WAS BETWEEN THE SATURATION OF PERIPHERAL OXYGEN (SPO2) AND ELECTROCARDIOGRAM (ECG) HEART RATE WHICH IS OFF BY ABOUT 50. NO PATIENT HARM REPORTED. NIHON KOHDEN CLINICAL SUPPORT (NK CAS) INFORMED THE NURSE THAT THERE IS NO SETTINGS THAT WOULD CAUSE THAT DISCREPANCY AND RECOMMEDED THAT IT COULD POSSIBLY BE THE WAY THEIR VITALS ARE BEING MAPPED TO THEIR ELECTRONIC MEDICAL RECORDS (EMR) SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14715248 ↗MalfunctionJan 23, 2021Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT THEY HAVE INSTALLED FOUR NEW WIRELESS BEDSIDE MONITORS (BSM) AND THEY WOULD RANDOMLY GO INTO COMMUNICATION LOSS. THEY WOULD WORK FOR MOST OF THE TIME AND THEN RANDOMLY GET COMMUNICATION LOSS. THE CUSTOMER STATED THAT WHEN THEY SEE COMMUNICATION LOSS, THE MOMENT THEY TAKE THE UNITS OUT OF THE ROOM, ITS COMMUNICATION WOULD BE RESTORED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11220350 ↗MalfunctionJan 23, 2021Communication or Transmission Problem; Communication or Transmission Problem
THE CUSTOMER REPORTED THAT THEY HAVE INSTALLED FOUR NEW WIRELESS BEDSIDE MONITORS ( BSM) AND THEY WOULD RANDOMLY GO INTO COMMUNICATION LOSS. THEY WOULD WORK FOR MOST OF THE TIME AND THEN RANDOMLY GET COMMUNICATION LOSS. THE CUSTOMER STATED THAT WHEN THEY SEE COMMUNICATION LOSS, THE MOMENT THEY TAKE THE UNITS OUT OF THE ROOM, ITS COMMUNICATION WOULD BE RESTORED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11220088 ↗MalfunctionFeb 13, 2020Output Problem; Power Problem; Complete Loss of Power; Output Problem; Power Problem; Complete Loss of Power
THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) DISPLAYED "INPUT UNIT FAILURE" DURING A PROCEDURE. THE CUSTOMER ALSO REPORTED THAT AFTER THEY REPLACED THE INPUT UNIT THEIR BSM AUDIBLY ALARMED AND DISPLAYED A BLUE SCREEN WITH ERROR CODES, AFTER WHICH IT SHUT DOWN ALL TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9709096 ↗MalfunctionJan 23, 2020Power Problem; Power Problem
THE CUSTOMER REPORTED THAT THEIR BEDSIDE MONITOR (BSM) REBOOTED ON ITS OWN DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9624714 ↗MalfunctionJan 13, 2020Pressure Problem; Pumping Problem; Pressure Problem; Pumping Problem
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR'S (BSM) NON-INVASIVE BLOOD PRESSURE (NIBP) PUMP WAS SOMETIMES GOING TO "40" AND KEPT PUMPING (THE CUFF WOULD NOT DEFLATE). THE CUSTOMER ALSO REPORTED THAT THE PUMP SOMETIMES GENERATED A READING, AND OTHER TIMES GENERATED AN "AIR LEAK ERROR" MESSAGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9583808 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A BRUISE ON A NEONATE PATIENT.
Patient problems: Bruise/Contusion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555516 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A REDDENED SKIN TEAR ON THE RIGHT WRIST OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555510 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A REDDENED PRESSURE AREA ON THE TOP OF THE RIGHT FOOT OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555509 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED AN OPEN ABRASION ON THE LEFT FOOT OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555507 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A REDDENED PRESSURE AREA ON THE RIGHT FOOT OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555503 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A BLISTER ON THE RIGHT HAND OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555501 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED A REDDENED PRESSURE AREA ON THE TOP OF THE LEFT FOOT OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555500 ↗InjuryMay 30, 2018Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem; Thermal Decomposition of Device; Device Operational Issue; Compatibility Problem
THE NURSING MANAGER REPORTED THAT AN SPO2 PROBE CAUSED AN OPEN ABRASION ON THE RIGHT FOOT OF A NEONATE PATIENT.
Patient problems: Abrasion; Injury; Patient Problem/Medical Problem; Pressure Sore/Ulcer
MAUDE report 7555499 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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