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

Model Number ORG-9110A

Device Problems Telemetry Discrepancy (1629); Communication or Transmission Problem (2896)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the org was in signal loss on five tele devices.They sent the device in for repair and it is currently awaiting 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 org was in signal loss on five tele devices.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, event problem and evaluation codes, additional manufacturer narrative.Additional information: follow up, additional information/ correction.The biomedical engineer reported that the org was in signal loss on five tele devices.They sent the device and the evaluation has been completed.No patient harm was reported.The reported problem of "5 receivers in signal loss" could not be duplicated through testing, troubleshooting and extended operation of the device.The unit operate to manufacturer's specifications.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018, customer stated that 5 transmitters were experiencing signal loss.The org receiver listed is associated with the five transmitters.Customer had rebooted the org receiver and the cns monitor, but the issue remained.Customer verified there were no signs of loose cables and switched ports in the org closet.The cns was able to maintain communication with other org receivers.The troubleshooting session narrowed down to two possibilities of failures: the cat5 network cable or this org receiver.Service requested: repair.Service performed: evaluation.Investigation result: org receiver was evaluated by nka repair center.The reported issue could not be duplicated.Device was sent back to customer.Customer had not reported additional issues with this org receiver.Due to the issue could not be duplicated at nka, and the resolution information is not available, the root cause of the reported signal loss associated with this org receiver could not be determined.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.Device evaluation.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that the org was in signal loss on five 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: 7308470
• MDR Text Key: 101507374
• Report Number: 8030229-2018-00056
• 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,Followup
• Report Date: 10/07/2019

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: 02/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2019
• Distributor Facility Aware Date: 10/03/2019
• Device Age: 88 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/01/2018; 10/03/2019
• Supplement Dates FDA Received: 04/19/2018; 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1