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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT
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NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT Back to Search Results
Model Number ORG-9700A
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org showed 9 teles in signal loss.Technical support (ts) asked the customer to power cycle the org and after doing that only 6 of the units still showed signal loss.The customer found out that those 6 units had no patients on.The customer later reported that intermittent signal loss is still happening.The customer requested onsite support.Ts is working with the customer to resolve the problem.There was no patient injury reported.
 
Event Description
The customer reported that the org showed 9 teles in signal loss.Technical support (ts) asked the customer to power cycle the org and after doing that only 6 of the units still showed signal loss.There was no patient injury reported.
 
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Brand Name
ORG-9700A
Type of Device
RECEIVER UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12858233
MDR Text Key283247947
Report Number2080783-2021-01990
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2021
Distributor Facility Aware Date10/24/2021
Device Age179 MO
Event Location Hospital
Date Report to Manufacturer11/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ZM TRANSMITTERS
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