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

Model Number ORG-9110A

Device Problems Loss of Power (1475); Communication or Transmission Problem (2896); Power Problem (3010)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they had a power outage.After that all the telemetry transmitters were showing in communication loss.The multiple patient receivers (orgs) shut down and did not boot up successfully.Nihon kohden technical support (tech support) had them reboot the orgs and the customer confirmed that the units are now displaying.Issue resolved.No patient harm was reported.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the org.Multiple patient receiver: model: org-9110a; sn: (b)(4).Central nurse's station: model: cns-6201a; sn: (b)(4).Telemetry transmitter(s): model: ni; sn: ni.

Event Description

The biomedical engineer (bme) reported that they had a power outage.After that all the telemetry transmitters were showing in communication loss.The multiple patient receivers (orgs) shut down and did not boot up successfully.Nihon kohden technical support (tech support) had them reboot the orgs and the customer confirmed that the units are now displaying.Issue resolved.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that they had a power outage, after which all telemetry transmitters were showing comm loss at the central nurse's station (cns).The multiple patient receivers (orgs) shut down and did not boot back up successfully.Nihon kohden technical support (tech support) had them reboot the orgs and the customer confirmed that the units were displaying properly.No patient harm or injury was reported.Investigation summary: unwanted changes of monitoring configuration could delay the recognition and management of sudden deteriorations in vital signs or cardiac rhythm.Real-time monitoring remains intact on bedside monitors that can still alert caregivers to changes in vital signs or heart rhythm.The root cause of communication loss is power outage.Nk tech support assisted the customer in bringing the org's back online and the issue was resolved.There is no evidence of an nk device malfunction.

Event Description

The biomedical engineer (bme) reported that they had a power outage, after which all telemetry transmitters were showing comm loss at the central nurse's station (cns).The multiple patient receivers (orgs) shut down and did not boot back up successfully.No patient harm 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
• 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: 12708754
• MDR Text Key: 279102309
• Report Number: 8030229-2021-01852
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: 03/23/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); TELEMETRY TRANSMITTERS; TELEMETRY TRANSMITTERS