MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) has a lot of signal loss to the telemetry.The bme set up a spare org into place to maintain monitoring of the patient and will send in the org for repair.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) has a lot of signal loss to the telemetry.The bme set up a spare org into place to maintain monitoring of the patient and will send in their org for repair.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.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was in signal loss with the telemetry transmitters.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Signal loss is an error message notifying the user of loss of network communication between the monitoring devices and the zm transmitters.Possible causes of a communication error message on a zm could be when the network cable or connector is disconnected or faulty, if the wireless router or hub is faulty, if the settings of the monitor are not the same as the zm or if there are duplicate ip addresses being used by more than one bed.Communication loss/signal loss may also occur due to issues with the customer's network environment.Network access point overload may cause an unstable network connection and may cause devices to randomly drop connection or cause the host table to become unbalanced.For transmitters, if they are assigned to adjacent channels of the network, there could be radio wave interference which may cause signal loss.Other devices in the hospital facility may also cause interference which could cause signal loss.Communication loss/signal loss may also occur after a power loss, as the network server may not properly boot up after an unexpected shutdown.The error message could be easily detected by the user, and they would be able to perform necessary monitoring adjustments which mitigates the issue.For wireless zm telemetry transmitters connected to the bedside monitor, a "signal loss" message is displayed rather than "communication loss" if the issue occurs between the org receiver and the zm transmitter.However, communication loss with the org receiver device would trigger a "communication loss" message for up to 8 connected zm transmitters.Other related events that may cause the issue are accidentally turning off the device, and accidentally unplugging the network cable of the monitored device or user error.Signal loss may also occur due to issues with the customer's network environment.A possible failure of the receiver cards is likely a result of hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The org was installed in 2015 with no history of previous complaints or servicing.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was in signal loss with the telemetry transmitters.No patient harm was reported.

• 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 ; 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: 15080750
• MDR Text Key: 304178801
• Report Number: 8030229-2022-02974
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• 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: 10/04/2023

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 Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TELEMETRY; TELEMETRY TRANSMITTERS