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

Model Number ORG-9110A

Device Problems Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this org is displaying signal loss.According to the customer, multiple sectors have gone to signal loss and it's gotten to the point where it is not possible to monitor patients anymore.They replaced the org and that stopped the signal loss error.Technical support (ts) asked the customer to put back the bad org into service to see if they see the error again; however, the customer didn't want to do that while monitoring patients.The customer will set up a test environment and confirm if they're still seeing the signal loss.There was no patient injury 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.Additional model information: concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that this org is displaying signal loss.There was no patient injury reported.

Event Description

The customer reported that the org was displaying signal loss.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the org was displaying signal loss for multiple sectors, which was affecting patient monitoring.No patient harm was reported.Investigation summary: we were able to confirm the reported issue was due to bad receiver cards, which needed replacing.Bad receiver cards can lead to the reported signal loss issue.The customer was shipped the replacement receiver cards as requested to resolve the issue.A review of the device history did not reveal any trends that would contribute to component failure that is related to the design or manufacturing of the device.Moreover, this was found to be the only issue at the facility in the past 3 (three) years for this device and issue.As such, this is an isolated event, and a significant trend that would warrant any further corrective action has not been observed.Trending will continue to be monitored for these devices, incident issues and causes.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6-b7 d10 attempt # 1: 10/04/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 10/11/2022 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied by stating they could not provide the requested information.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.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-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: 15671401
• MDR Text Key: 307026562
• Report Number: 8030229-2022-03132
• Device Sequence Number: 1
• Product Code: DRG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2012
• 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: ZM TRANSMITTERS; ZM TRANSMITTERS