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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 Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/28/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org was in signal loss on multiple tele devices. 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 customer reported that the org was in signal loss on multiple tele devices. No consequence or impact to patient.
 
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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, 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, 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
MDR Report Key8070695
MDR Text Key127874153
Report Number8030229-2018-00423
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/13/2020
Distributor Facility Aware Date01/13/2020
Device Age156 MO
Event Location Hospital
Date Report to Manufacturer01/13/2020
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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