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

Model Number ORG-9110A

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

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

Event Date 12/02/2023

Event Type  malfunction  

Event Description

The customer reported that this unit was displaying intermittent communication loss (comm loss).There was no patient injury reported.

Manufacturer Narrative

The customer reported that this unit was displaying intermittent communication loss (comm loss).According to the customer, it will work for about 45 minutes to an hour and then go into comm loss for about 1-2 minutes.Technical support (ts) advised the customer to switch the port that the unit is plugged into; however, the customer chose to change the org unit.Ts walked the customer through the steps of changing the unit.The unit was not in patient use at the time.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have and can'g give out the patient information.B6 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have and can'g give out the patient information.B7 attempt # 1: 12/07/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; we don't have and can'g give out the patient information.Additional model information: d10 concomitant medical device: the following device were used in conjunction with the org: zm transmitters: model #: zm-531pa serial #: (b)(6) device manufacturer date: 12/13/2016 unique identifier (udi) #: (b)(4).Returned to nihon kohden: no model #: zm-531pa serial #: (b)(6) device manufacturer date: 12/20/2021 unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18409894
• MDR Text Key: 331513391
• Report Number: 8030229-2023-03979
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2013
• 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