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 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they were continuing to have signal loss for the telemetry transmitters (teles) after replacing the faulty 90 degree coax connector.Nk technical service account manager (tsam) went on site with a spectrum analyzer and determined that the adaptive antenna control (aac) on the a side of the antenna system had failed and caused intermittent signal loss.The aac was then replaced.Issue resolved.The issue was not with the multiple patient receiver (org) itself but with the components of the 3rd-party antenna system that is used with the org.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6, b6 - b7, d10 concomitant medical device.Attempt #1 09/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/14/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station(s): model: ni.Sn: ni.Zm telemetry transmitter(s): model: ni.Sn: ni.Wmts amp, adaptive antenna control (aac) dual band: model: um-9720a-2.Sn: ni.

Event Description

The biomedical engineer (bme) reported that they were continuing to have signal loss for the telemetry transmitters (teles) after replacing the faulty 90 degree coax connector.Nk technical service account manager (tsam) went on site with a spectrum analyzer and determined that the adaptive antenna control (aac) on the a side of the antenna system had failed and caused intermittent signal loss.The aac was then replaced.Issue resolved.The issue was not with the multiple patient receiver (org) itself but with the components of the 3rd-party antenna system that is used with the org.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that they were continuing to have signal loss for the telemetry transmitters (teles) after replacing the faulty 90 degree coax connector.Nk technical service account manager (tsam) went on site with a spectrum analyzer and determined that the adaptive antenna control (aac) on the a side of the antenna system had failed and caused intermittent signal loss.The aac was then replaced.Issue resolved.The issue was not with the multiple patient receiver (org) itself but with the components of the 3rd-party antenna system that is used with the org.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that they were continuing to have signal loss for the telemetry transmitters (teles) after replacing the faulty 90 degree coax connector.Nk technical service account manager (tsam) went on site with a spectrum analyzer and determined that the adaptive antenna control (aac) on the a side of the antenna system had failed and caused intermittent signal loss.The aac was then replaced.Issue resolved.The issue was not with the multiple patient receiver (org) itself but with the components of the 3rd-party antenna system that is used with the org.No patient harm was reported.Investigation conclusion: on-site support was sent to the customer.It was discovered that one of the aacs on the antenna system had failed causing the noise floor on both the a and b sides to be out of range.The aac was replaced and the noise floor was tested to be within acceptable range.Failure of an aac is likely a result of hardware failure.Hardware failure could come as a result of physical, fluid, heat, 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 following fields are not applicable (na) to the mdr report: the following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device attempt #1 09/12/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/13/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 09/14/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Central nurse's station(s) model: ni.Sn: ni.Zm telemetry transmitter(s) model: ni.Sn: ni.Wmts amp, adaptive antenna control (aac) dual band model: um-9720a-2.Sn: ni.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17753047
• MDR Text Key: 323524693
• Report Number: 8030229-2023-03785
• Device Sequence Number: 1
• Product Code: DRG
• 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: Literature,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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: 08/17/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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: CENTRAL NURSE'S STATION(S); CENTRAL NURSE'S STATION(S); UM-9720A-2; UM-9720A-2; ZM TRANSMITTER(S); ZM TRANSMITTER(S)