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

Model Number ORG-9110A

Device Problem Radiofrequency Interference (RFI) (2314)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is having issues with signal loss and high interference.The device was returned and the reported problem of "high interference" was duplicated, but the "signal loss" could not be duplicated.Nihon kohden tested the org with a -3khz and +3khz shift, and the +3khz failed.To resolve the issue, all 8 old version ad receivers were replaced with current version ag receivers.The software version was upgraded from 03-05 to 04-20 per customer request.Tested and completed all steps in the maintenance check sheet per the service manual.Device operates to manufacturer's specifications.

Event Description

The customer reported that the org is having issues with signal loss and high interference.

Manufacturer Narrative

Details of complaint: on 12/28/2017 customer reported org receiver device org-9110a serial number (b)(6) was experiencing signal loss and high interference issues.Customer requested to send device to nka for the latest firmware update.The firmware version on this device was 03-05.Nka repair center evaluated the device.High signal interference was observed; however, the signal loss issues could not be duplicated.The device was tested at -3khz and + 3khz shift, the +3khz failed.Eight ad receiver cards in the org device were replaced with the current ag receiver cards.The firmware was upgraded from 03-05 to 04-20 as customer requested.The reported issue was resolved after the above activities.Service requested: evaluation and repair.Service performed: evaluation and repair.Investigation result: the current incident does not elaborate on "high interference" issue.Service history for this user facility shows two previous incidents of reported spo2 parameters being "spiked": tickets (b)(4).In july 2019, an investigation into the spo2 spiking related to org-9110a receivers were conducted under (b)(4).The investigation concluded on 12/26/2019 with the following conclusion: "it was found that the reception sensitivity deteriorated depending on the device and when the change of the frequency characteristic shifted to the + direction." of the 11 devices analyzed, 10 were used past the service life."the frequency characteristics of zr-920p slightly change depending on the individual initial characteristics and aging." this failure mode is associated with aging of the device."revision ag of zr-920p, the filter peripheral circuit has been changed to absorb the change of the frequency characteristic." it is recommended to replace zr-920p as failure occurs.Org-9110a serial number (b)(6) was placed into service on 11/30/2012.Service history for this org device shows the following: 01/20/2018 300110525 - customer requested software update from 03-05 to 04-20.Update was performed as requested.12/28/2017 300108161 - current incident.05/05/2017 300083580 - customer reported org device was experiencing signal loss on one of the eight receiver cards.A resolution as not documented.This was not related to the "high interference" reported under the current incident.Due to insufficient information provided under the current incident, a connection between "high interference" and "spo2 spiking" investigation could not be made.The root cause of the "high interference" could not be determined.Device's service history shows this does not represent a trend.Investigation conclusion due to insufficient information provided under the current incident, a connection between "high interference" and "spo2 spiking" investigation could not be made.The root cause of the "high interference" could not be determined.Device's service history shows this does not represent a trend.

Event Description

The customer reported that the org is having issues with signal loss and high interference.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7220529
• MDR Text Key: 98421917
• Report Number: 8030229-2018-00030
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Distributor Facility Aware Date: 01/06/2020
• Device Age: 64 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Patient Outcome(s): Death