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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC. TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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NIHON KOHDEN AMERICA, INC. TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number ORG-9110A
Device Problem Computer Software Problem (1112)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was discovered on [date redacted] at 13:02 that the arrhythmia recall was not recording or updating on cardiac monitors. Then on [date redacted] at 11:04, we were notified that prefense was not storing non-invasive blood pressure (nibp) readings. Last evening, [date redacted], notified that prefense was not storing any information. After reboot the issue was corrected, but the device was still not saving nibp readings. Made nihon kohden aware on [date redacted] of issues related to the wmts digital telemetry receiver system. The manufacturer was also updated on [date redacted] related to prefense issues. Followed up with them multiple times. Learned that this is a nationwide issue, and that it will require a software update that they need to build. The company report that they are working on it but will still be several weeks. They did provide a work around to this in the interim but it is cumbersome and not ideal for the folks using the system or working with and monitoring the patients.
 
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Brand NameNA
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
NIHON KOHDEN AMERICA, INC.
15353 barranca pkwy
irvine CA 92618
MDR Report Key11257779
MDR Text Key229655625
Report Number11257779
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/28/2021
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer02/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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