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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER
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NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problems Output Problem (3005); Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) on the 5th floor has been experiencing an ongoing signal loss to the transmitters in several rooms and departments in their hospital.No patient harm or missed patient events reported.Nihon kohden technician went on-site and found that the attenuators' (aac) were defective which the nk technician replaced and issue is resolved.Attenuators are not considered to be medical devices.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org) on the 5th floor has been experiencing an ongoing signal loss to the transmitters in different rooms and departments in their hospital.No patient harm or missed patient events reported.Nihon kohden technician went on-site and found that the attenuators' (aac) were defective which the nk technician replaced and issue is resolved.Attenuators are not considered to be medical devices.Central nurse stations: model #: ni.Serial #: ni.Zm transmitters: model #: ni.Serial #: ni.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the multiple patient receiver (org) on the 5th floor has been experiencing an ongoing signal loss to the transmitters in different rooms and departments in their hospital.No patient harm or missed patient events reported.Nihon kohden technician went on-site and found that the attenuators' (aac) were defective which the nk technician replaced and issue is resolved.Attenuators are not considered to be medical devices.Investigation summary: on-site support identified that the cause of the intermittent signal loss was due to a defective amplifier combiners or aac.Aac's are used to adjust the gains on signals and connect between the org and its' antennas.Defective aac's may prevent proper signal strength from being outputted or stop signals completely.Based on the sales data of this customer, these aac's were most likely installed in 1/2018 when the org was first used in their facility.The root cause is most likely related to wear and tear a complaint history review reveals there is no history for the aac failure, therefore a corrective action or preventative action (capa) is not warranted.Additional manufacturer narrative b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type h6 type of investigation code h10 additional narrative/data.
 
Event Description
The biomedical engineer (bme) reported that the multiple patient receiver (org) on the 5th floor has been experiencing an ongoing signal loss to the transmitters in several rooms and departments in their hospital.No patient harm or missed patient events reported.Nihon kohden technician went on-site and found that the attenuators' (aac) were defective which the nk technician replaced and issue is resolved.Attenuators are not considered to be medical devices.
 
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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
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 Key14078145
MDR Text Key289358435
Report Number8030229-2022-02768
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/21/2022
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-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2022
Initial Date FDA Received04/11/2022
Supplement Dates Manufacturer Received06/03/2022
Supplement Dates FDA Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
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 STATION; CENTRAL NURSE STATION; TRANSMITTERS; TRANSMITTERS
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