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

Model Number ORG-9100A

Device Problem Device Difficult to Maintain (3134)

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

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurses station (cns) will restart whenever the customer tries to admit or discharge for a specific patient, bed id: s-425.Customer was advised to switch the location of s-425 to s-426's location.When switched, s-425 experienced the same issue, when as s-426 experienced no issue.Customer sent in their device for evaluation and was sent a loaner.The unit was cleaned and evaluated.The reported problem was not duplicated.The transmitter was tested with the channel number connected to the cns.Testing included admitting and discharging on all 8 sectors one at a time, however the cns did not restart.All steps in the maintenance check sheet were tested and completed per the service manual.The unit completed 3 days of extended testing and operates to manufacturer's specifications.Customer was notified that the reported issue could not be duplicated.Device was returned to the customer as is.

Event Description

The customer reported that the central nurses station (cns) will restart whenever the customer tries to admit or discharge for a specific patient, bed id: s-425.

Manufacturer Narrative

Details of complaint on (b)(6) 2018 customer stated that cns application would restart when a particular telemetry patient was being discharged or admitted.The patient was under bed (b)(6).With the assistance of nk tech support, the issue was isolated to org receiver s/n (b)(6) over the phone.When device was sent into to nka for evaluation, the reported issue could not be duplicated.The org receiver performed per specification without triggering the cns application to restart.Service requested: repair.Service performed: evaluation.Investigation result: device was put into service on 4/27/2017.Service history shows this is an isolated incident for this device.It has not re-occurred since (b)(6) 2018.Service history for this facility also shows this is an isolated incident.Due to the issue could not be duplicated under test environment, and details regarding the setup at the time of the incident was not available, the root cause of the issue could not be determined.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects.

Event Description

The customer reported that the central nurses station (cns) will restart whenever the customer tries to admit or discharge for a specific patient, bed id: (b)(6).

• 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: 7777675
• MDR Text Key: 117299622
• Report Number: 8030229-2018-00310
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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: 07/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Distributor Facility Aware Date: 10/22/2019
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CN.