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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multiple patient receiver (org-9110a) failed and displayed an "error light" message, causing comm loss at the central nurse's station (cns) and the remote network station (rns).The cns and rns were monitoring 8 tele beds.No consequence or impact to the patients were reported.No consequence or impact to the patients were reported.Nihon kohden sent the customer an exchange org to resolve the issue.The defective org was returned to nihon kohden and is awaiting evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Additional model information: the following devices were being used in conjunction with the org: cns, rns, tele devices.No model and serial information is known as attempts to obtain information were made, but not provided.

Event Description

The customer reported that the multiple patient receiver (org-9110a) failed and displayed an "error light" message, causing comm loss at the central nurse's station (cns) and the remote network station (rns).The cns and rns were monitoring 8 tele beds.No consequence or impact to the patients were reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multiple patient receiver (org-9110a) failed, displaying an "error light" message, causing comm loss at the central nurse's station (cns) and the remote network station (rns).The cns and rns were monitoring 8 tele beds.No patient harm was reported.Nihon kohen technical support (nkts) advised the customer to power cycle the org, but the issue persisted.The caller stated they were not trained to reconfigure the org, requesting to send the unit in for an exchange.An exchange unit was shipped to the customer on 09/10/2019.No patient harm was reported.Service requested / performed: exchange / evaluation: no physical damage was noticed.Upon repair center (rc) evaluation, the reported problem was duplicated.An "invalid crc-32 value in rom" error message was displayed.On 05/22/2020, the org was reprogrammed to sw ver 03-31, which resolved the issue.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 48 hours of extended testing and operated to the manufacturer's specifications.Investigation summary: the possible causes for a crc error to appear when using a computer, are corruption of a file or program registry, file and setting configuration mistakes, and/or faulty app or program installations.A problem with the hard drive can also cause a cyclic redundancy check data error.The overall risk of this event is determined to be medium.The reported issue does not require further investigation through capa process since the issue is known to be caused due to factors outside of nk device capabilities.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the org: cns: model #: ni; serial #: ni.Rns: model #: ni; serial #: ni.Transmitters: model #: ni; serial #: ni.

Event Description

The customer reported that the multiple patient receiver (org-9110a) failed and displayed an "error light" message, causing comm loss at the central nurse's station (cns) and the remote network station (rns).The cns and rns were monitoring 8 tele beds.No consequence or impact to the patients was reported.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 9084859
• MDR Text Key: 165547390
• Report Number: 8030229-2019-00474
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/18/2019,08/23/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Distributor Facility Aware Date: 08/28/2019
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS,RNS,TELES.; CNS,RNS,TELES.