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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problem Radiofrequency Interference (RFI) (2314)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org is having issues with signal loss and high interference. The device was returned and the reported problem of "high interference" was duplicated, but the "signal loss" could not be duplicated. Nihon kohden tested the org with a -3khz and +3khz shift, and the +3khz failed. To resolve the issue, all 8 old version ad receivers were replaced with current version ag receivers. The software version was upgraded from 03-05 to 04-20 per customer request. Tested and completed all steps in the maintenance check sheet per the service manual. Device operates to manufacturer's specifications.
 
Event Description
The customer reported that the org is having issues with signal loss and high interference.
 
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Brand NameORG-9110A
Type of DeviceMULTIPLE PATIENT RECEIVER
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 Key7220529
MDR Text Key98421917
Report Number8030229-2018-00030
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 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2020
Distributor Facility Aware Date01/06/2020
Device Age64 MO
Event Location Hospital
Date Report to Manufacturer01/06/2020
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2012
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

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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