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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC. NIHON KOHDEN; CARDIAC MONITOR
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NIHON KOHDEN AMERICA, INC. NIHON KOHDEN; CARDIAC MONITOR Back to Search Results
Model Number BSN-6701
Device Problem Defective Alarm (1014)
Patient Problem No Code Available (3191)
Event Date 03/29/2018
Event Type  No Answer Provided  
Event Description
During crrt pt developed a life threatening rhythm and the nk monitor did not alarm.The first sign was a low bp alarm followed by the crisis alarm 3 minutes after for extreme bradycardia not the ventricular rhythm.The monitor was removed from service and sent to the main facility in (b)(4) to conduct a full evaluation of the product.Pmn of cad, dm, chf s/p biv icd, htn who presented on with worsening left leg weakness and pain.Ct lumbar spine showed severe stenosis l3-4, b/l neural foraminal stenosis l5-s1 as well as inflammatory changes surrounding l kidney.Patient underwent lumbar laminectomy l1-4 for cauda equina syndrome and bilateral ureteral stent placement for pyonephrosis with renal failure.
 
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Brand Name
NIHON KOHDEN
Type of Device
CARDIAC MONITOR
Manufacturer (Section D)
NIHON KOHDEN AMERICA, INC.
MDR Report Key7464558
MDR Text Key106791609
Report NumberMW5076788
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/10/2018
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? No
Device Operator Health Professional
Device Model NumberBSN-6701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/25/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight113
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