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

Model Number ORG-9100A

Device Problems Device Issue (2379); Communication or Transmission Problem (2896)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the rssi values for all of the receivers on one org are either too high or too low.The customer was provided with a loaner and sent the org in to nihon kohden for repair.The device has been received and will undergo evaluation.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 if additional information becomes available.

Event Description

The biomedical engineer reported that the rssi values for all of the receivers on one org are either too high or too low.

Manufacturer Narrative

The biomedical engineer (bme) reported that the rssi values for all of the receivers on one org are either too high or too low.The customer was provided with a loaner and sent the org in to nihon kohden for repair.The device was cleaned and evaluated.The reported problem of "receivers on this org are either too high or too low" was duplicated.The org had old version ad receivers installed, that is what was causing too high or too low waveforms.Replaced all 8 receivers with newer version ah.Tested and completed all steps in the maintenance check sheet per the service manual.Please inform customer of the evaluation.All malfunction parts were replaced.The unit was tested per the operator's/service manual.All malfunctioning parts were replaced.The unit was tested per the operator's/service manual.The unit completed 24 hours of extended testing and operates to manufacturer's specification.

Event Description

The biomedical engineer reported that the rssi values for all of the receivers on one org are either too high or too low.

Manufacturer Narrative

Details of complaint: on 4/18/2018 customer reported rssi values for all receiver card on org-9100a serial number (b)(4) were either too high or too low.Device was sent to nka for evaluation and repair.Nka repair center evaluated the device.The reported issue was confirmed.Eight zr-920p receiver cards were replaced to resolve the issue.Service requested: evaluation and repair.Service performed: evaluation and repair.Investigation result: in july 2019, an investigation into the spo2 spiking (relating to wireless signal reception sensitivity) of 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-9100a serial number 190 was placed into service on 6/28/2009.Service history for this org device shows the following: on 07/25/2018 300132884 - customer reported rssi value issues relating to signal sensitivity.The issue could not be duplicated.Customer had duplicate wireless channels that needed to be reprogrammed.This is not relating to the issue under the current ticket.On 07/09/2018 300131085 - not related to the issue under current incident.On 04/18/2018 300122256 - current incident.Based on the above investigation, the root cause of the reported rssi issues were due to zr-920p needing replacement.This service was performed by nka repair center.The above service history shows this is not representative of a trend.Investigation conclusion: based on the above investigation, the root cause of the reported rssi issues were due to zr-920p needing replacement.This service was performed by nka repair center.The above service history shows this is not representative of a trend.

• Brand Name: ORG-9100A
• 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: 7523171
• MDR Text Key: 108614719
• Report Number: 8030229-2018-00162
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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,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-9100A
• Device Catalogue Number: ORG-9100A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Distributor Facility Aware Date: 01/06/2020
• Device Age: 113 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 01/06/2020
• Supplement Dates FDA Received: 06/29/2018; 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1