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 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) does not connect to the network and cannot see any of the telemetry transmitters on the central nurse' station (cns).This happened after a storm occurred, causing a switch to fail and creating a loss in network communication.Unplugging the ac power and plugging it back in resulted in restoring the network connection throughout, however, this org did not come back up.After, troubleshooting, nk technical support suggested that they send the org in for evaluation, but it has not yet been received.No patient harm reported.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.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) does not connect to the network and cannot see any of the telemetry transmitters on the central nurse' station (cns).This happened after a storm occurred, causing a switch to fail and creating a loss in network communication.No patient harm reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) network reported the multiple patient receiver (org-9110a sn: (b)(6) did not connect to the network and the customer was unable to see any of the beds in the cns.There was a storm a few days prior (saturday) which caused a switch connected to the org to disconnect and network communication was lost.Service requested: repair.Service performed: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: there was no physical damages while initial evaluation.Verify the complaint: an org-9110a did not connected to the cns and can't see any receivers.Problem reported was duplicated.We replaced the following parts below and issue is resolved.Ur-39801 zr mother board for org-9100 1 ea ur-3981 cpu board for org-9100 1 ea all the malfunctioning part(s) were replaced.The unit was tested per the operator's/service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation result: the org warranty began 11/28/2015.Review of device sap history found no previously reported issues with the unit.Nka repair center evaluation confirmed the org was unable to connect to the cns and see receivers.Issue was resolved upon replacing the zr motherboard #: ur-39801 and the cpu board #: ur-3981.Approximate age of the org was 4 years.Issue occurred during a storm which caused a network switch to disconnect.It is unknown if the org lost power as well, or if the org and switch were connected to a ups at the time.From the information available, the root cause could not be determined.Unit has no trend of reported network communication issues.Issue was resolved upon servicing and tested to operate within specifications.Investigation conclusion: from the information available, the root cause could not be determined.Unit has no trend of reported network communication issues.Issue was resolved upon servicing and tested to operate within specifications.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.H3.Device evaluated by manufacturer.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) does not connect to the network and cannot see any of the telemetry transmitters on the central nurse' station (cns).This happened after a storm occurred, causing a switch to fail and creating a loss in network communication.No patient harm reported.

• 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: 9121042
• MDR Text Key: 199138057
• Report Number: 8030229-2019-00492
• 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: 12/09/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Distributor Facility Aware Date: 12/02/2019
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1