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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; TRANSMITTER
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NIHON KOHDEN CORPORATION; TRANSMITTER Back to Search Results
Device Problems Application Program Problem (2880); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the gz transmitter discharged and erased the patient information and the telemetry summary.The biomed tried working on the unit, but it continues to discharge the patient.The floor telemetry technician has to go into the patients room, take the battery out of the unit and remove the telemetry wires.At this time, they have 10 seconds to discharge the sector and then the telemetry tech installs the telemetry battery.Cmu then attempts to readmit the patient so that no heart rhythm information is lost.This process sometimes has to be repeated 2-3 times before the equipment will allow the sector to be readmitted.At 0226, the process was successful and the patient was readmitted.This malfunction is very frustrating for the 7 tower staff and the cmu staff.Not to mention that the device is not storing patient heart rhythm and / or spo2 information during this time.No patient harm reported.
 
Event Description
The biomedical engineer reported that the gz transmitter discharged and erased the patient information and the telemetry summary.The biomed tried working on the unit, but it continues to discharge the patient.The floor telemetry technician has to go into the patients room, take the battery out of the unit and remove the telemetry wires.At this time, they have 10 seconds to discharge the sector and then the telemetry tech installs the telemetry battery.Cmu then attempts to readmit the patient so that no heart rhythm information is lost.This process sometimes has to be repeated 2-3 times before the equipment will allow the sector to be readmitted.At 0226, the process was successful and the patient was readmitted.This malfunction is very frustrating for the 7 tower staff and the cmu staff.Not to mention that the device is not storing patient heart rhythm and / or spo2 information during this time.No patient harm reported.
 
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Brand Name
NI
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 116-8 560
JA  116-8560
MDR Report Key11325687
MDR Text Key270274233
Report Number2080783-2021-00070
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 Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2021
Distributor Facility Aware Date01/13/2021
Event Location Hospital
Date Report to Manufacturer02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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