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

Model Number ORG-9100A

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Manufacturer Narrative

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 patients that were monitored on this multiple patient receiver (org) at the time were apparently discharged and cannot be readmitted.They have rebooted the org twice, and the issue persists.There are no error lights.The other org is operating fully and correctly.When trying to admit a telemetry patient on this failed org, the admit screen will only appear for a moment and then disappear.They initially rebooted the incorrect org; and once the correct org was rebooted, the issue was resolved.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitters monitored on this multiple patient receiver (org) were apparently discharged from the central nurse's station (cns and could not be re-admitted.They tried rebooting the org twice, but the issue persisted.There were no error lights.When trying to admit a telemetry transmitter on this org, the admit screen would only appear for a moment then disappear.They initially rebooted the incorrect org; and once the correct org was rebooted, the issue was resolved.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitters monitored on this multiple patient receiver (org) were apparently discharged from the central nurse's station (cns and could not be re-admitted.They tried rebooting the org twice, but the issue persisted.There were no error lights.When trying to admit a telemetry transmitter on this org, the admit screen would only appear for a moment then disappear.They initially rebooted the incorrect org; and once the correct org was rebooted, the issue was resolved.No patient harm was reported.Investigation summary: loss of patient monitoring could delay the recognition and management of sudden deteriorations in vital signs or cardiac rhythm.As a clinician is present during the admission of a patient, loss of patient monitoring after admitting a patient is likely to be noticed and the patient's condition could be assessed.As the device was not returned for evaluation, a root cause cannot be determined.No further issues have been reported with the device.A complaint history review revealed no related ticket for the device reported.Due to this issue being the only occurrence identified in complaints trending, this event is likely to be an isolated incident.As the customer reported that the issue was resolved by rebooting the org, a possible root cause is likely to be related to the customer's network environment.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• Brand Name: ORG-9100A
• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12791803
• MDR Text Key: 280948078
• Report Number: 8030229-2021-01948
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: TELEMETRY TRANSMITTER(S).; TELEMETRY TRANSMITTER(S).