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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 Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the org is causing noise-artifact. No consequence or impact to the patients were reported. Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
It was reported that the org is causing noise-artifact. No consequence or impact to the patients.
 
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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 Key8579913
MDR Text Key144408975
Report Number8030229-2019-00124
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 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2019
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 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 FDA11/21/2019
Distributor Facility Aware Date11/19/2019
Event Location Hospital
Date Report to Manufacturer11/21/2019
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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