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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

The customer reported that they are having the same issue as previously reported in (b)(6) communication dropouts, and an error led is on the multiple patient receiver (org) that will not turn off.There was no patient injury reported.

Manufacturer Narrative

The customer reported that they are having the same issue as previously reported in (b)(6) communication dropouts, and an error led is on the multiple patient receiver (org) that will not turn off.The customer will send in the unit to be exchanged as the issue keeps happening.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: d10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: ni serial (b)(6) device manufacturer date: ni unique identifier (udi) (b)(4) returned to nihon kohden: no additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni serial (b)(6) device manufacturer date: ni 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: 18563982
• MDR Text Key: 333480315
• Report Number: 8030229-2024-04026
• 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
• Report Date: 01/23/2024

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: 12/27/2023
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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; ZM TRANSMITTERS