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	11/21/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (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, per the fda request.
Event or Problem 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.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18337509
• Report Number: 8030229-2023-03943
• Device Sequence Number: 12497063
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883(21)1048
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/24/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 02/28/2024; 02/28/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 02/29/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2015
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; ZM TRANSMITTERS; ZM TRANSMITTERS; ZM TRANSMITTERS
• Patient Sex: Unknown