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

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time.No patient(s) were harmed.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 device information: concomitant medical device: the following device(s) were in use in conjunction with the org: central nurse's station: model #: pu-681ra, serial #: (b)(4), device manufacturer data: 07/24/2018, unique identifier (udi) #: (b)(4).Transmitter: model #: zm-520pa, serial #: ni, device manufacturer data: ni, unique identifier (udi) #:(b)(4).

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time.No patient(s) were harmed.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) was showing intermittent comm loss for the monitored telemetry transmitters at the central nurse's station (cns) for about 2-10 seconds at a time.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) was showing intermittent comm loss for the monitored telemetry transmitters at the central nurse's station (cns) for about 2-10 seconds at a time.No patient harm or injury was reported.Investigation summary: this issue was originally reported on ticket 115117.This ticket was created to have a sperate report for this serial number ( (b)(6) ).A third serial number ( (b)(6) ) was listed as having the reported signal loss issue as well.The root cause is determined to be the facility's network environment.A review of the serial number history ( (b)(6) ) shows no recurrence of reported issue.A review of the facility history shows multiple issues related to the reported issue.Of those reported, none are for serial numbers (b)(6) nor (b)(6).The issues reported for the facility are all previous to the current event or are voided out as duplicate tickets.Of the previous tickets reported, the root causes identified were related to facility network causes.There are multiple reasons a "signal loss" message can appear.These can include weak transmitter batteries, incorrect antenna settings, electromagnetic interference, and incorrect electrode lead placement.Because most network and signal loss issues are due to hospital network settings, connection errors, or other use errors, issues of this type are unlikely to be caused by a device malfunction.Due to the complex nature of hospital network systems, these issues may recur despite correctly functioning equipment.

• 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: 12371940
• MDR Text Key: 268535800
• Report Number: 8030229-2021-01667
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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 PU-681RA.; PU-681RA.; TRANSMITTERS ZM-520PA.; ZM-520PA.