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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  
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.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
 
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.
 
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
Details of the complaint & service requested / performed: incident summary: on (b)(6) 2021 the customer reported that "the battery for the unit became so hot that it started to smoke and give off fumes." the customer did verify that there was no physical damage inside the battery compartment and mentioned that the battery appears to be normal.The customer also mentioned that the battery is approximately five years old.The device was returned to nka for evaluation and repair.The model, serial number, and all labels were verified.No physical damage to the battery was noted, but the repair technician did observe physical damage to the front case/touch screen of the unit and the connectors of the ecg input and the dpu pcb of the unit.The following components were replaced to repair the unit: ur-4237 dpu, bsm-1753a rpk-ur4250 kit, ecg bd 6111904486a front enclosure, and 9000035044a touch panel.Investigation conclusion: this device was put into service on (b)(6) 2017.The service history for this serial number shows a previous report issued on (b)(6) 2021 (ref.(b)(4)).The unit was returned for a cracked screen.This is evidence that the unit has suffered from physical damage in the past.Root cause: testing performed on the device indicates that the battery is operating as intended and is not defective.This suggests that a defective battery is unlikely to be a contributing factor to the issue.During the evaluation, it was noted that the bsm suffered physical damage.The damage to the bsm is not from normal use, and it suggests that it may have suffered from an external force.Based on the available information, a definitive root cause could not be identified.However, warnings on the operator's manual of bsm-1700, indicate that a battery malfunction, such as overheating, explosion, and fire may occur when 1.Battery is left near a heat source 2.Battery is charged using on unspecified instruments 3.Battery pack is charged outside the specified environment (over 40 °c or 104 °f) or high temperature areas 4.Strong impact on the battery.Risk analysis summary: the device is designed with an internal battery pack.When undocked from the host monitor, the bsm-1753 will operate from the battery pack.Therefore, if the battery pack is functioning properly, the bsm shall operate correctly.The overall risk score is a product of severity x probability.Per definitions in the risk assessment table, the overall risk score is medium.The issue is found to be a single occurrence and is an isolated incident.
 
Event Description
The biomedical engineer (bme) reported that the battery for the bedside monitor (bsm) became so hot it started to smoke and give off fumes.They looked inside the battery compartment and could not see any indication of heat damage.The battery looked normal, but they noticed that it was almost 5 years old.Not in patient use.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the battery for the bedside monitor (bsm) became so hot it started to smoke and give off fumes.They looked inside the battery compartment and could not see any indication of heat damage.The battery looked normal, but they noticed that it was almost 5 years old.The device was returned to nka for evaluation and repair.No patient harm or injury was reported.Investigation summary: on 8/2/2021 nihon kohden america (nka) evaluated the bsm and battery and could not duplicate the issue.The battery operated normally for 24 hours.Damage to dpu pcb was observed, and the touchscreen was cracked.Nka replaced the following components: ur-4237 dpu, bsm-1753a rpk-ur4250 kit, ecg bd 6111904486a front enclosure, 9000035044a touch panel.The evaluation results were sent to nihon kohden corporation (nkc) in japan to help in further determining the cause of the heat and smoke phenomenon.There was insufficient information for the investigation.The reported issue was not duplicated, and the cause is unknown.There have been no reports of similar phenomenon with this family of device.There is no recurrence history for this device or family of device.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type?.H6 event problem and evaluation codes.H10 additional manufacturer narrative.
 
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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
Manufacturer (Section G)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-1 tajino
tomioka city, gunma 370-2 314
JA   370-2314
Manufacturer Contact
shama mooman
seibu bldg 2, 4th floor 1-11-2
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key12029191
MDR Text Key280787546
Report Number8030229-2021-00355
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921111871
UDI-Public4931921111871
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/02/2023
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? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2021
Initial Date FDA Received06/18/2021
Supplement Dates Manufacturer Received04/01/2022
05/01/2023
Supplement Dates FDA Received04/28/2022
05/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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