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 10/10/2023

Event Type  malfunction  

Event Description

The customer reported that this org has 3 of the 8 receiver cards frequently displaying signal loss.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this org has 3 of the 8 receiver cards frequently displaying signal loss.The customer will send in the unit to be repaired.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.B6 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.B7 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.D10 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; i will not be able to provide any patient demographics.

Manufacturer Narrative

Details of complaint: the customer reported that this org has 3 of the 8 receiver cards frequently displaying signal loss.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: the reported issue was duplicated and confirmed.After further investigation from repair center, they determined that there were 7 receiver cards that were giving frequent unstable respiratory rates.All 7 receiver cards were replaced to resolve the issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.B6 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.B7 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i will not be able to provide any patient demographics.D10 attempt # 1: 01/11/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; i will not be able to provide any patient demographics.Manufacturer references (b)(4) follow up 001.

Event Description

The customer reported that this org has 3 of the 8 receiver cards frequently displaying signal loss.There was no patient injury 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18503972
• MDR Text Key: 333332505
• Report Number: 8030229-2024-04060
• 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: 01/18/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2014
• 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