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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR
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NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR Back to Search Results
Model Number BSM-1753A
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that they were told by the hospital's fire team last night that the battery for the bedside monitor (bsm) became so hot that it started to smoke and give off fumes.The caller stated that they have looked inside the battery compartment and could not see any indication of damage caused by the battery becoming hot enough to smoke and give off fumes.They stated that the battery looks normal, but did notice that the battery is almost 5 years old.Sending the customer a replacement battery.It is coming in for evaluation.The customer stated that this bsm was a stand-alone bedside monitor.Not in patient use.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that they were told by the hospital's fire team last night that the battery for the bedside monitor (bsm) became so hot that it started to smoke and give off fumes.The caller stated that they have looked inside the battery compartment and could not see any indication of damage caused by the battery becoming hot enough to smoke and give off fumes.They stated that the battery looks normal, but did notice that the battery is almost 5 years old.Sending the customer a replacement battery.It is coming in for evaluation.The customer stated that this bsm was a stand-alone bedside monitor.Not in patient use.
 
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Brand Name
BSM-1753A
Type of Device
VITAL SIGNS MONITOR
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12029228
MDR Text Key280787495
Report Number2080783-2021-00355
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921111871
UDI-Public4931921111871
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBSM-1753A
Device Catalogue NumberBSM-1753A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2021
Distributor Facility Aware Date05/19/2021
Device Age51 MO
Event Location Hospital
Date Report to Manufacturer06/18/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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