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

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9100a multiple patient receivers.It is unclear what was causing their issues - environmental, device failure, network, etc.Our technical support team followed up with the biomed to further troubleshoot and was told that they are not sure what initially caused the signal loss or how the issue was resolved and that their telemetry department was no longer having signal loss issues.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 there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9100a multiple patient receivers.It is unclear what was causing their issues - environmental, device failure, network, etc.Our technical support team followed up with the biomed to further troubleshoot and was told that they are not sure what initially caused the signal loss or how the issue was resolved and that their telemetry department was no longer having signal loss issues.

Manufacturer Narrative

H10: additional narrative: details of complaint: customer biomed (b)(4) stated four transmitters were experiencing intermittent signal loss.She was not on site during the call in.The signal loss duration was 5-10 seconds.During the signal loss, the monitoring cns showed numeric data went from numbers to 3 dashes, the wave forms were not displayed, and a signal loss error was generated.Triangle waves were never displayed on the cns.There were also some instances of noise and artifacts which also lasted briefly (less than 5 seconds), but she was unsure if the noise was on the cns or on both devices.Customer was provided with instructions for narrow down the possible causes for further troubleshooting.The affected org receiver device information was provided: org-9100a, serial no.(b)(6).The org-9100a is a multiple patient receiver that simultaneously receive wireless signal from transmitter devices.This signal is then relayed to the cns for monitoring.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: when nk ts followed up with customer regarding the issue, it was reported that the issue was resolved the following business day.Customer was unsure of what caused the issue or how it was resolved.Service history for org-9100a serial no.(b)(6) shows there are no other tickets created.This is not a known issue for this unit.Based on the service history, a common root cause of the signal loss issue at this hospital site is due to environmental interference.In this particular incident, there was not enough information to determine a root cause.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Please see attached dhr review form.The root cause could not be determined.No additional incidents have been reported since (b)(6) 2019.Corrected information: g4.Date received by manufacturer: should be 04/13/2019 not 05/08/2019 as listed on mdr initial report.

Event Description

The biomedical engineer reported that there are multiple transmitters with intermittent signal loss while monitoring patients.The transmitter signals are being transmitted using the org-9100a multiple patient receivers.It is unclear what was causing their issues - environmental, device failure, network, etc.Our technical support team followed up with the biomed to further troubleshoot and was told that they are not sure what initially caused the signal loss or how the issue was resolved and that their telemetry department was no longer having signal loss issues.

• 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: 8592031
• MDR Text Key: 144457066
• Report Number: 8030229-2019-00141
• 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
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2019
• Distributor Facility Aware Date: 07/08/2019
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: TRANSMITTERS