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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 Communication or Transmission Problem (2896); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the org was in signal loss on two tele devices. After some troubleshooting, it was decided that they would switch the org out for a known working one, which resolved the issue. The failure was found to be with two receivers on the failed org device. No patient harm was reported.
 
Event Description
The biomedical engineer reported that the org was in signal loss on two tele devices.
 
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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, 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 Key7249642
MDR Text Key99313498
Report Number8030229-2018-00037
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 10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/23/2019
Distributor Facility Aware Date10/04/2019
Device Age109 MO
Event Location Hospital
Date Report to Manufacturer10/23/2019
Date Manufacturer Received10/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2008
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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