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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).The customer found loose cables on the antennas, splitters, and power supplies for the antenna system.They stated that after the cable connections were tightened they have not seen any signal loss.No patient harm 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.Concomitant medical device: the following devices were being used in conjunction with the org.Central nurse's station: model: cns-6201a, sn: (b)(4).

Event Description

The biomedical engineer reported that there was intermittent signal loss being displayed on the central nurse's station (cns).The customer found loose cables on the antennas, splitters, and power supplies for the antenna system.They stated that after the cable connections were tightened they have not seen any signal loss.No patient harm reported.

Manufacturer Narrative

Details of complaint: the customer reported that their multiple patient receiver (org) was experiencing intermittent signal dropouts.This issue was occurring throughout the facility.A nihon kohden technical support (nk ts) field support team was to be scheduled to be on site to troubleshoot further.No patient harm or injury was reported.Service requested / performed: troubleshooting.Investigation summary: on-site support found that the amplifier combiner, the customer was using with their antennas, had a defective port causing the antenna connected to that port to be unresponsive.Moving the antenna to a working port resolved the issue of signal loss.The amplifier combiner is a third-party product.As such a capa is not warranted.

Event Description

The biomedical engineer reported there was intermittent signal loss displayed at the central nurse's station (cns).The customer found loose cables on the antennas, splitters, and power supplies for the antenna system.Once the cable connections were tightened, no additional signal loss was displayed.No patient harm was 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10400246
• MDR Text Key: 202704271
• Report Number: 8030229-2020-00446
• 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: 08/12/2020,06/15/2022

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Distributor Facility Aware Date: 07/15/2020
• Device Age: 72 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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
• Treatment: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6); TELEMETRY TRANSMITTERS; CNS-6201A SN (B)(4).