• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Disconnection (1171); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org had signal loss on 11 of the connected transmitters. There were cables being pulled on-site at the time the event occured. The biomed was to check the org wiring closet and the war room switches for wiring and power issues. 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 the org had signal loss on 11 of the connected transmitters.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported that the org had signal loss on 11 of the connected transmitters. There were cables being pulled on-site at the time the event occured. The biomed was to check the org wiring closet and the war room switches for wiring and power issues. The device was never sent in for evaluation. Due to the age of this complaint additional information necessary to conduct an investigation is not readily available. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available. Device not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORG-9100A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
gunma 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
2687488
MDR Report Key5797400
MDR Text Key50450738
Report Number8030229-2016-00335
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 07/14/2016,06/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2016
Distributor Facility Aware Date06/14/2016
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer07/14/2016
Date Manufacturer Received07/14/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/16/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-