Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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-9110A; 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-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s).No patient harm was reported.Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org's) keep losing connectivity and shows communication loss with connected device(s).No patient harm was reported.Nihon kohden's technician advised the bme to work with their it department due to having nihon kohden's equipment running off of their facilities network which means the switches being used for the org's are serviced by the facilities it department.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORG-9110A
Type of Device
MULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12457018
MDR Text Key281148341
Report Number2080783-2021-01645
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Distributor Facility Aware Date08/15/2021
Device Age66 MO
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MULTIPLE PATIENT RECEIVER'S ORG'S; MULTIPLE TELEMETER(S)
-
-