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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 Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the org had communication loss on multiple channels. They tried power cycling the unit and initializing it, however the issue continued to persist. Nihon kohden no longer stocks the motherboard and receivers for this model, so the customer was referred to his sales rep for the replacement of the equipment. The bme called back for assistance setting up the new equipment, which resolved the issue. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The biomedical engineer reported that the org had communication loss on multiple channels. They tried power cycling the unit and initializing it, however the issue continued to persist.
 
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Brand NameORG-9700A
Type of DeviceRECEIVER UNIT
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, gunma 370-2 314
JA 370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
2687488
MDR Report Key6412116
MDR Text Key70180429
Report Number8030229-2017-00073
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 03/16/2017,02/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2017
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/16/2017
Distributor Facility Aware Date02/17/2017
Device Age133 MO
Event Location Hospital
Date Report to Manufacturer03/16/2017
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2006
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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