Life Scope L BSM-2354ARecalls & reported problems

Nihon Kohden Corporation · Bedside Monitor · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 11
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04931921101728), received between Jan 30, 2017 and Sep 12, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (5 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

Device problems

No Display/Image5
Device Operates Differently Than Expected2
Deflation Problem1
Device Inoperable1
Device Stops Intermittently1
Electrical /Electronic Property Problem1
Erratic or Intermittent Display1
Improper Device Output1

Patient problems

No Known Impact Or Consequence To Patient11
No Consequences Or Impact To Patient2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 12, 2018Erratic or Intermittent Display; Erratic or Intermittent Display
THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DISPLAY SCREEN ON THE BEDSIDE MONITOR (BSM) WAS INTERMITTENTLY GOING WHITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7871295 ↗
MalfunctionMay 30, 2018No Display/Image; No Display/Image
THE BIOMEDICAL ENGINEER REPORTED THAT THE DISPLAY SCREEN ON THE BEDSIDE MONITOR (BSM) WAS GOING WHITE INTERMITTENTLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7555484 ↗
MalfunctionNov 14, 2017Electrical /Electronic Property Problem; Device Stops Intermittently; Intermittent Loss of Power; Electrical /Electronic Property Problem; Device Stops Intermittently; Intermittent Loss of Power
THE CUSTOMER REPORTED THAT THIS BEDSIDE MONITOR (BSM) WAS POWERING OFF/ON BY ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 7031537 ↗
MalfunctionOct 20, 2017No Display/Image; No Display/Image
THE NURSE REPORTED THAT THE DEVICE SCREEN ON THE BEDSIDE MONITOR (BSM) IS COMPLETELY BLANK BLACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6966966 ↗
MalfunctionOct 19, 2017No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT THE SCREEN ON THEIR BEDSIDE MONITOR (BSM) IS ALL WHITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6963443 ↗
MalfunctionSep 14, 2017No Display/Image; No Display/Image
THE NURSE REPORTED THAT THE DISPLAY SCREEN ON THE BEDSIDE MONITOR (BSM) WAS INTERMITTENTLY GOING WHITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6867071 ↗
MalfunctionJun 27, 2017Wireless Communication Problem; Wireless Communication Problem
THE BIOMEDICAL ENGINEER REPORTED THAT THEIR BEDSIDE MONITORS (BSM) EXPERIENCED INTERMITTENT COMMUNICATION LOSS WITH THE CENTRAL NURSE'S STATION (CNS).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6671668 ↗
MalfunctionJun 16, 2017No Display/Image; No Display/Image; Improper Device Output
THE CUSTOMER REPORTED THAT THE DISPLAY ON THE BEDSIDE MONITOR WAS NOT CLEAR.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6649020 ↗
MalfunctionApr 18, 2017Loss of Power; Device Operates Differently Than Expected; Noise, Audible; Device Operates Differently Than Expected
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR RANDOMLY SHUTS OFF AND MAKES A HIGH PITCH SOUND.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6500112 ↗
MalfunctionFeb 3, 2017Device Inoperable; Device Inoperable
THE CUSTOMER REPORTS THAT THE CONNECTION ON THE BEDSIDE MONITOR IS GOING BAD CAUSING THE SCREEN TO FADE TO WHITE. IF THE LEFT SIDE OF THE MONITOR IS TAPPED OR SQUEEZED THE CONNECTION GETS INTERRUPTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6301071 ↗
MalfunctionJan 30, 2017Deflation Problem; Device Operates Differently Than Expected; Device Operates Differently Than Expected
THE CUSTOMER REPORTED THAT THE BEDSIDE MONITOR WILL NOT DEFLATE THE NIBP CUFF.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6285607 ↗

Device details

UDI-DI	`04931921101728`
Brand	Life Scope L
Model	BSM-2354A
Company	Nihon Kohden Corporation
Product code	MHX · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 4, 2024

Device type (GMDN): General-purpose multi-parameter bedside monitor

An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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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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