MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9100A
Medical Device Problem Codes	Signal Artifact/Noise (1036); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.
Additional Manufacturer Narrative
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.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.Additional device information: concomitant medical device: the following device(s) was used in conjunction with the org: zm transmitters: model #: zm-530pa.Serial #: (b)(4).Device manufacturer data: 03/01/2017.Unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.Investigation summary: customer declined a loaner org and reported this org no longer needs repair.The customer did not provide information on how the issue of communication loss was resolved.No further issues were reported for the org-9100a s/n 271.Root cause cannot be determined.As resolution did not involve assistance from nka, the issue is unlikely to be a result of an nk device malfunction.The root cause for the communication loss is most likely related to customer network environment.As the issue of communication loss could not be confirmed to be cause by a device malfunction and no further issues were reported following this event, a corrective and or preventative action (capa) is not warranted.The following fields are not applicable (na) to this report: the following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 01/06/2022 customer called and informed nihon kohden technical support that they will not be returning the org and do not want the loaner org sent to them.Did not provide any further information on the status of the device.Attempt # 2: 01/16/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 01/17/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the org: zm transmitters: model #: zm-530pa.Serial #: (b)(6).Device manufacturer data: 03/01/2017.Unique identifier (udi) #: (b)(4).
Event or Problem Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) keeps getting a signal loss from one transmitter while monitoring a patient in their room.The bme swapped to a different transmitter but the issue is still there.No patient harm was reported.Nihon kohden technician advised the bme that it is likely the receiver card in the org and recommended that they send in the org for repair.Customer declined returning the org to nihon kohden.

• Brand Name: ORG-9100A
• Common Device Name: 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 Key: 13266565
• Report Number: 8030229-2022-02393
• Device Sequence Number: 1546466
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZM TRANSMITTERS; ZM TRANSMITTERS
• Patient Sex: Unknown