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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR
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NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR Back to Search Results
Model Number BSM-1733A
Device Problems Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that they were connecting the transport bedside monitor bsm-1733a to a bsm-6000 series bedside monitor when a spark happened, and the connection of the bsm-1700 was charred.The bsm-1733a does not seem to work at all after this either.Nihon kohden technical support (tech support) advised the customer to send the unit in with the battery so that nihon kohden can do a thorough investigation.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 connecting the transport bedside monitor bsm-1733a to a bsm-6000 series bedside monitor when a spark happened, and the connection of the bsm-1700 was charred.The bsm-1733a does not seem to work at all after this either.Nihon kohden technical support (tech support) advised the customer to send the unit in with the battery so that nihon kohden can do a thorough investigation.Not in patient use.
 
Event Description
The biomedical engineer (bme) reported that when connecting the transport bedside monitor bsm-1733a to a bsm-6000 series bedside monitor (bsm) a spark occurred, charring the connector on the bsm-1733a.The bsm-1733a was no longer working following the spark.The bsms were not in patient use.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that when connecting the transport bedside monitor bsm-1733a to a bsm-6000 series bedside monitor (bsm) a spark occurred, charring the connector on the bsm-1733a.The bsm-1733a was no longer working following the spark.They sent the bsm-1733a in for an exchange.The bsms were not in patient use.Investigation summary: nihon kohden corporation (nkc) engineer investigated the reported phenomenon: (1) the detailed information of the bsm-6000 could not be obtained.(2) the log of the bsm-1700 was obtained and analyzed, and there was no abnormal log.(3) in observing the photo that was sent from nka, it was found that the blackened area on the bsm-1700 was a gnd connector terminal and +12v power supply line.(4) it was confirmed that the fire-retarding material was used for the blackened connection part, and it would not lead to fire or the spread of fire.Although the detailed information of the bsm-6000 could not be obtained, it was determined that the device had worked normally as it was reported there was no damage and there was no repair information following the incident.Since it was reported that the host unit (bsm-6000) was not influenced, it was supposed that the phenomenon of sparking during connection occurred on the bsm-1700.As a result of checking the photo which sent from nka, it was confirmed that the area between the +12v power supply line and gnd connector terminal was burnt.It was presumed that a short circuit occurred because a foreign object had gotten into the area between the +12v power supply line and gnd connector terminal, and the connection area was burnt when connecting to the power supply.There has been no report of a similar phenomenon with this family of device, and no recurrence history for this device.The definitive root cause was not identified.
 
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Brand Name
BSM-1733A
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 Key12921775
MDR Text Key286145909
Report Number8030229-2021-02019
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921111833
UDI-Public4931921111833
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
Report Date 05/03/2023
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-1733A
Device Catalogue NumberBSM-1733A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2021
Initial Date FDA Received12/02/2021
Supplement Dates Manufacturer Received05/02/2023
Supplement Dates FDA Received05/03/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/03/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
BEDSIDE MONITOR; BEDSIDE MONITOR
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