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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN TOMIOKA CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Intermittent Continuity (1121); Device Inoperable (1663); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2015
Event Type  malfunction  
Manufacturer Narrative
The customer reported that there was intermittent signal loss across the network but once nihon kohden technical support had him reboot the device, all began to work except for one transmitter that the customer called back later for an exchange.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 there was intermittent signal loss across the network but once nihon kohden technical support had him reboot the device, all began to work except for one transmitter that the customer called back later for an exchange.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
ORG-9100A
Type of Device
MULTIPLE PATIENT RECEIVER
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 Key5328166
MDR Text Key34939456
Report Number8030229-2015-00462
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 12/24/2015,11/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/24/2015
Distributor Facility Aware Date11/25/2015
Device Age39 MO
Event Location Hospital
Date Report to Manufacturer12/24/2015
Date Manufacturer Received12/24/2015
Date Device Manufactured08/29/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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