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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 Problem Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that the patients that were monitored on this multiple patient receiver (org) at the time were apparently discharged and cannot be readmitted.They have rebooted the org twice, and the issue persists.There are no error lights.The other org is operating fully and correctly.When trying to admit a telemetry patient on this failed org, the admit screen will only appear for a moment and then disappear.They initially rebooted the incorrect org; and once the correct org was rebooted, the issue was resolved.No patient harm was reported.
 
Event Description
The biomedical engineer (bme) reported that the patients that were monitored on this multiple patient receiver (org) at the time were apparently discharged and cannot be readmitted.They have rebooted the org twice, and the issue persists.There are no error lights.The other org is operating fully and correctly.When trying to admit a telemetry patient on this failed org, the admit screen will only appear for a moment and then disappear.They initially rebooted the incorrect org; and once the correct org was rebooted, the issue was resolved.No patient harm was reported.
 
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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 Key12791847
MDR Text Key285058208
Report Number2080783-2021-01948
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 11/10/2021
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 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 FDA11/10/2021
Distributor Facility Aware Date10/15/2021
Device Age54 MO
Event Location Hospital
Date Report to Manufacturer11/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TELEMETRY TRANSMITTER(S)
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