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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 Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/21/2023
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bsm) reported that the 5 telemetry transmitters went into communication loss.The customer found this was caused by the multiple patient receiver (org) that had failed.Not in patient use.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 biomedical engineer (bsm) reported that the 5 telemetry transmitters went into communication loss.The customer found this was caused by the multiple patient receiver (org) that had failed.Not in patient use.
 
Event Description
The biomedical engineer (bsm) reported that 5 telemetry transmitters went into comm loss at the central nurses station (cns).The customer found that the multiple patient receiver (org) had failed, causing the communication loss.No patients were being monitored at the time.
 
Manufacturer Narrative
Details of complaint: the biomedical engineer (bsm) reported that 5 telemetry transmitters went into comm loss at the central nurses station (cns).The customer found that the multiple patient receiver (org) had failed, causing the communication loss.No patients were being monitored at the time.Investigation summary: the org was sent in for evaluation and repair.During the evaluation of the returned device nihon kohden repair center (nk rc) was not able to duplicate the reported issue of communication loss.Instead, an error led was found lit and the org was unable to be accessed during the evaluation.The cpu board was recommended to be replaced.It is likely that the communication loss was related to the failure of the cpu board.Hardware failure could come as a result of physical damage, fluid damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.The device was installed in march 2017 with no previous history of servicing or repairs.The root cause of cpu board failure is likely related to wear and tear.Additional device information: d10: concomitant medical device: the following devices were used in conjunction with the org, but model and serial number information is listed as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1 11/28/2023 emailed customer via microsoft outlook for additional device information.The customer responded with complaint details, but did not provide the requested device information.Central nurse's station: model: ni sn: ni zm telemetry transmitters: model: ni sn: ni.
 
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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
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key18337509
MDR Text Key330982267
Report Number8030229-2023-03943
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 02/29/2024
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
Date Returned to Manufacturer11/28/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received12/15/2023
Supplement Dates Manufacturer Received02/28/2024
Supplement Dates FDA Received02/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2015
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
CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; ZM TRANSMITTERS; ZM TRANSMITTERS
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