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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Signal Artifact/Noise (1036); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.
 
Event Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.
 
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Brand Name
ORG-9100A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key13266562
MDR Text Key287021426
Report Number2080783-2022-02393
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103883
UDI-Public04931921103883
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 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/17/2022
Distributor Facility Aware Date12/23/2021
Device Age145 MO
Event Location Hospital
Date Report to Manufacturer01/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ZM TRANSMITTERS
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