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

Model Number ORG-9110A

Device Problems Radio Signal Problem (1511); Device Issue (2379); Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the org was in signal loss on multiple tele devices.They were advised to restart the device, check the switch and call back if the issue persists.No patient harm was reported.

Event Description

The biomedical engineer reported that the org was in signal loss on multiple tele devices.

Manufacturer Narrative

Details of complaint: on 2/8/2018 customer reported several telemetry transmitters were experience communication loss.Customer was advised to reboot the org and check the network switch.Customer was to call back to confirm resolution.Additional follow up attempts did not yield a response.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: service history for the org receiver shows one additional communication loss incident: ticket (b)(4) - reported on 1/3/2019.The communication loss incidents were resolved by rebooting the org.The root cause could not be determined.-- service history for this facility shows the following communication loss incidents: (b)(4) - reported 4/23/2019.Not related to org receivers.(b)(4) - reported on 1/3/2019.The communication loss incidents were resolved by rebooting the org.The root cause could not be determined.37321 - reported 8/19/2018.Four telemetry transmitters were showing communication loss on the cns.The root cause could not be determined due to insufficient information provided.Customer did not respond to further inquiries.36364 - reported 8/5/2018.Not related to org receivers.In the current ticket and in (b)(4), org was causing the communication.However, the root cause as to why communication loss occurred could not be determined, due to insufficient data.Since the last reported org issue on 1/3/2019, there has been no other org related issues at this facility.Additional information: b4.Date of this report f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? additional information h6.Event problem and evaluation codes h10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that the org was in signal loss on multiple tele devices.

• 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: 7325313
• MDR Text Key: 101996045
• Report Number: 8030229-2018-00060
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: TRANSMITTERS