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

Model Number	ORG-9100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that this multiple patient receiver (org) is experiencing intermittent communication loss.Their central nurse's station (cns) did not notify them of this communication loss and they only found out about it by reviewing the org logs.The customer changed their patients from transmitters to bedside monitors in order to get the communication loss issue to go away.No harm or injury was 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.Additional device information: concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that this multiple patient receiver (org) is experiencing intermittent communication loss.Their central nurse's station (cns) did not notify them of this communication loss and they only found out about it by reviewing the org logs.The customer changed their patients from transmitters to bedside monitors in order to get the communication loss issue to go away.No harm or injury was reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the multiple patient receiver (org) was experiencing intermittent communication loss.The central nurse's station (cns) did not notify them of the communication loss, which they discovered when reviewing the org logs.No patient harm was reported.Investigation summary: as the customer was not able to provide device logs in a timely manner required for analysis, a root cause of the communication loss could not be determined.The cause for the initial occurrence was related to network configuration as the cns's ip was not entered into the host table.Possible causes of communication loss from the org may include incompatible software versions between the org and cns, or user error with the org's network settings, such as incorrect network communication protocol.The customer should ensure devices within the patient monitoring network are on compatible software versions and on the same net protocol setting.A review of the device's serial number does not show any other complaints.Attempt #1 03/29/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 04/05/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 04/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that the multiple patient receiver (org) was experiencing intermittent communication loss.The central nurse's station (cns) did not notify them of the communication loss, which they discovered when reviewing the org logs.No harm or injury was reported.
Additional Manufacturer Narrative
This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The customer reported that the multiple patient receiver (org) was experiencing intermittent communication loss.The central nurse's station (cns) did not notify them of the communication loss, which they discovered when reviewing the org logs.No harm or injury was reported.

• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14094824
• Report Number: 8030229-2022-02733
• Device Sequence Number: 5967392
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883(21)1459
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 08/09/2024

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
• 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: 03/13/2022
• Supplement Date Received by Manufacturer: 10/04/2023; 10/04/2023
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 10/05/2023; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2021
• 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: CNS; CNS; CNS
• Patient Sex: Unknown