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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Failure to Cycle (1142); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2015
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org has 2 receiver cards with the rssi values of 4. The customer has power cycled the org and the value remained at 4. 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 has 2 receiver cards with the rssi values of 4. The customer has power cycled the org and the value remained at 4.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported that the org has 2 receiver cards with the rssi values of 4. The customer has power cycled the org and the value remained at 4. Power cycling the org resolved the issue. The rssi value was at 10. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available. Device not returned.
 
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Brand NameORG-9100A
Type of DeviceMULTIPLE PATIENT RECEIVER
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
486 nanokaichi
attn: shama mooman
gunma 370-2 343
JA 370-2343
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
2687708
MDR Report Key5365646
MDR Text Key36275021
Report Number8030229-2016-00017
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,Followup
Report Date 01/13/2016,12/23/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2016
Distributor Facility Aware Date12/23/2015
Device Age90 MO
Event Location Hospital
Date Report to Manufacturer01/13/2016
Date Manufacturer Received01/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2008
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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