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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN TOMIOKA CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the consignment org had signal loss on two receiver cards. The customer will receive an exchange to replace the defective org. 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 consignment org had signal loss on two receiver cards.
 
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Brand NameORG-9110A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA 370-2314
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA 370-2314
Manufacturer Contact
susan shadley
1-31-4 nishiochiai, shinjuku-k
attn: susan shadley
tokyo, japan 161-8-560
JA   161-8560
2687133
MDR Report Key6032173
MDR Text Key57721398
Report Number8030229-2016-00507
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 10/14/2016,09/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2016
Distributor Facility Aware Date09/14/2016
Device Age47 MO
Event Location Hospital
Date Report to Manufacturer10/14/2016
Date Manufacturer Received10/14/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/09/2012
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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