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-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 Communication or Transmission Problem (2896)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the central nurse's station (cns) monitoring patients is in communication loss.They went to the multiple patient receiver (org) closet and found that it had no power and had failed.No patient harm reported.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.Concomitant medical device: the following devices were being used in conjunction with the org.Central nurse's station: model: cns-6801a.Sn: (b)(4).Telemetry transmitter: model: zm-530pa.Sn: (b)(4).Telemetry transmitter: model: zm-530pa.(b)(4).Telemetry transmitter: model: zm-530pa.Sn: (b)(4).Telemetry transmitter: model: zm-530pa.Sn: (b)(4).Telemetry transmitter: model: zm-530pa.Sn: (b)(4).
 
Event Description
The customer reported that the central nurse's station (cns) monitoring patients is in communication loss.They went to the multiple patient receiver (org) closet and found that it had no power and had failed.No patient harm reported.
 
Manufacturer Narrative
Details of complaint: the customer reported that the central nurse's station (cns) monitoring patients is in comm loss.They went to the multiple patient receiver (org) closet and found that there was no power to the device and it had failed.No patient harm was reported.Service requested / performed: evaluation / repair.Investigation summary: the evaluation revealed the cause of the communication loss to be a defective cpu board.No physical damage was observed during evaluation.The device was installed at the customer's facility in 02/2009 and has no previous history of repair or maintenance.The root cause for the defective cpu board leading to communication loss is most likely related to normal wear and tear.Due to the root cause likely being wear and tear and the improbable occurrence, a capa is not warranted.
 
Event Description
The customer reported that the central nurse's station (cns) monitoring patients is in comm loss.They went to the multiple patient receiver (org) closet and found that there was no power to the device and it had failed.No patient harm was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ORG-9100A
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
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
attn: shama mooman
1-1 tajino
tomioka city, 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
MDR Report Key10165101
MDR Text Key195640574
Report Number8030229-2020-00314
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103883
UDI-Public04931921103883
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/17/2020,06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2020
Distributor Facility Aware Date05/26/2020
Device Age140 MO
Event Location Hospital
Date Report to Manufacturer06/17/2020
Initial Date Manufacturer Received 05/26/2020
Initial Date FDA Received06/17/2020
Supplement Dates Manufacturer Received06/09/2022
Supplement Dates FDA Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CNS-6801A SN (B)(6) ; CNS-6801A SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA SN (B)(6) ; ZM-530PA (B)(4); ZM-530PA (B)(4); ZM-530PA (B)(4); ZM-530PA (B)(4); ZM-530PA (B)(4); ZM-530PA (B)(4)
-
-