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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ORG-9700A RECEIVER UNIT

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NIHON KOHDEN TOMIOKA CORPORATION ORG-9700A RECEIVER UNIT Back to Search Results
Model Number ORG-9700A
Device Problem Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/05/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org was in communication loss on all receivers. He unplugged the power and ethernet cable and then plugged them back in, however the issue persisted. The customer sent the unit in for repair. The unit was cleaned and evaluated. The reported problem of communication loss was duplicated. The motherboard was changed to fix this issue. The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet. The unit was tested and operates to manufacturer's specifications. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
 
Event Description
The customer reported that the org was in communication loss on all receivers.
 
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Brand NameORG-9700A
Type of DeviceRECEIVER UNIT
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
tomioka city, japan 370-2 343
JA 370-2343
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
tomioka city, japan 370-2 343
JA 370-2343
Manufacturer Contact
thomas bento
1-31-4 nishiochia, shinjuku-ku
tokyo, japan 161-8-560
JA   161-8560
2687708
MDR Report Key6301024
MDR Text Key66503627
Report Number8030229-2017-00022
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/03/2017,01/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2017
Distributor Facility Aware Date01/05/2017
Device Age29 MO
Event Location Hospital
Date Report to Manufacturer02/03/2017
Date Manufacturer Received02/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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