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

Model Number	ORG-9100A
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not working after trying to setup hiq view feature.They tried to setup hiq view and rebooted the org and now it will not boot up.No patient harm 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 field contains no information (ni), as attempts to obtain information were made, but not provided.Telemetry transmitter(s) model: ni.Sn: ni.
Event or Problem Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not working after trying to setup hiq view feature.They tried to setup hiq view and rebooted the org and now it will not boot up.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bsm) reported that the multiple patient receiver (org) was not booting back up after a control reboot following an attempt to set up the hiq view feature.No patient harm was reported.Investigation summary: during the course of troubleshooting, nihon kohden technical support (nk ts) discovered that the customer was not using the appropriate software version of putty and did not have the appropriate connection cable to connect the org to their laptop.The customer was advised to address these issues before additional troubleshooting would be performed.Nk ts followed up with the customer for status updates, but they were left unanswered.The root cause is likely related to the use of incompatible software and/or use of an incompatible connecting cable.The following fields contains no information (ni), as an attempt to obtain the information was made, but not provided.A2 - a6.B6 - b7.D10.Attempt #1 03/14/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but did not provide the requested information.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Telemetry transmitters: model: ni.Sn: ni.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not booting back up after a control reboot following an attempt to set up the hiq view feature.No patient harm was reported.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.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.Additional information: b4 data of this report g6 type of report h2 if follow up, what type?.
Event or Problem Description
The biomedical engineer (bsm) reported that the multiple patient receiver (org) was not booting back up after a control reboot following an attempt to set up the hiq view feature.No patient harm 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: 13881202
• Report Number: 8030229-2022-02727
• Device Sequence Number: 17482360
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883(21)499
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 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: 02/24/2022
• Supplement Date Received by Manufacturer: 10/04/2023; 10/04/2023
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 10/06/2023; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2010
• 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: TELEMETRY TRANSMITTER(S).; TELEMETRY TRANSMITTERS.; TELEMETRY TRANSMITTERS.
• Patient Sex: Unknown