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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org is displaying communication loss (comm loss).According to the customer, they have to reboot the unit in order to correct the comm loss message.The issue happens randomly, but once they reboot the org, the issue goes away; however, the issue returns a few days later.The issue happens 1-2 times a week.Technical support (ts) suggested for the customer to check the ports and switch; however, the customer was not on-site.The customer will have the tech reach out to troubleshoot the issue.
 
Event Description
The customer reported that the org is displaying communication loss (comm loss).There was no patient injury reported.
 
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Brand Name
ORG-9110A
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 Key12965454
MDR Text Key285697704
Report Number2080783-2021-02104
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
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 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/08/2021
Distributor Facility Aware Date11/11/2021
Device Age40 MO
Event Location Hospital
Date Report to Manufacturer12/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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