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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 Problem Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
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.
 
Manufacturer Narrative
The bedside monitor bsm-6000 series: model: ni, sn: ni.
 
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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
MDR Report Key12921828
MDR Text Key285564723
Report Number2080783-2021-02019
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921111833
UDI-Public4931921111833
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/02/2021
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-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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2021
Distributor Facility Aware Date11/02/2021
Device Age30 MO
Event Location Hospital
Date Report to Manufacturer12/02/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BEDSIDE MONITOR
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