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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patients were 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 customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patient.

Event Description

The customer reported that the org is dropping its signal on transmitters that are attached to it.No consequence or impact to the patient.

Manufacturer Narrative

On (b)(6) 2019, bme (b)(6) health reported the multiple patient receiver (org-9110a sn:(b)(6)) had intermittent signal loss.This was also occurring on a couple other random transmitters.The signal loss was frequent and about a second in duration to a few seconds.Earlier, the signal loss was much longer on some beds.Service requested troubleshooting/assistance.Service performed customer was advised to find what org the "signal loss" telemeters were on and reboot the orgs.A loaner was sent to the customer, which the customer reported had the ground stud pushed in and a note saying "issues on some receiver cards".It seems the customer received a broken device.This loaner was exchanged in ticket 56101.Customer reported the issue still existed with the second (undamaged) loaner org.Customer was provided the floor plans and antenna diagrams, and the areas affected were narrowed.Results of nk onsite troubleshooting: -found a non-nk access point in the vicinity (between antenna 2-b43 and 2-a45).-extensive construction going on in the hospital for months.Pulling cable in the ceilings and moving around up there.New plumbing and tubs in the hospital.New cath lab.Roofing.Etc.-at 8:26 pm and some seconds, 2 of the transmitters in use went into signal loss at the exact same time for the exact same duration.-have not noticed any flickering or power outages on any of the antenna.-further down the hallway around aac 2-a/b16, when walking around, found some dropout.But when walking down the other hallway, nothing drops out.Not a lot of tele in that area.Recommended we power down that access point and see if anything changes.Also recommended if we could not do that, we will need to get rssi values at some point.Follow up was sent to the customer, to which customer responded: this ticket is resolved but i don't think the root cause was corrected.My best assessment is that the shielding of some cables were compromised while work was being performed in the ceilings, and that there was something being operated at the same times of evening on the same days of the week that was causing interference.We are still determining the best course forward, but it is not the org on this ticket.Investigation result the device was put into service on 06/08/18, which is less than 1 year prior to the reported issue.A review of device history found no previously reported issues with the unit or nka servicing performed.The issue was not isolated to the org.Additionally, the issue was not resolved upon replacing the org with another unit.The issue is likely not caused by a deficiency of the unit itself.Nk troubleshoot found there was extensive construction at the hospital for months.Additionally, customer was using a non-nk access point.It is unknown if these contributed to the signal loss.The information provided suggests the issue is not isolated to or caused by any one unit or model.Possible root cause is an environmental factor, such as interference or construction, or an issue with supporting accessory, such as access point.This is a known issue at the facility and issues with signal loss is detected at the cns.The signal loss affects transmission of patient information from the telemetry monitoring devices to the org, which then communicates to the cns.Other patient monitoring devices, such as bedside monitors, are not affected by this issue.The device was in use with a patient and there was no reported patient harm.Based on the given information, this issue is not suspected to be caused by deficient device and the complaint record will be closed.

• 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: 8566894
• MDR Text Key: 143620195
• Report Number: 8030229-2019-00132
• 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: 07/19/2019

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: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2019
• Distributor Facility Aware Date: 07/03/2019
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2019
• Initial Date Manufacturer Received: 04/07/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1