• 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 Problem Device Difficult to Maintain (3134)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/14/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the central nurses station (cns) will restart whenever the customer tries to admit or discharge for a specific patient, bed id: s-425. Customer was advised to switch the location of s-425 to s-426's location. When switched, s-425 experienced the same issue, when as s-426 experienced no issue. Customer sent in their device for evaluation and was sent a loaner. The unit was cleaned and evaluated. The reported problem was not duplicated. The transmitter was tested with the channel number connected to the cns. Testing included admitting and discharging on all 8 sectors one at a time, however the cns did not restart. All steps in the maintenance check sheet were tested and completed per the service manual. The unit completed 3 days of extended testing and operates to manufacturer's specifications. Customer was notified that the reported issue could not be duplicated. Device was returned to the customer as is.
 
Event Description
The customer reported that the central nurses station (cns) will restart whenever the customer tries to admit or discharge for a specific patient, bed id: s-425.
 
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, 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 Key7777675
MDR Text Key117299622
Report Number8030229-2018-00310
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 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2018
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 NumberNOT APPLICABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/24/2019
Distributor Facility Aware Date10/22/2019
Device Age24 MO
Event Location Hospital
Date Report to Manufacturer10/24/2019
Date Manufacturer Received10/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
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

-
-