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 Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multiple patient receiver (org) started displaying signal loss for 4 transmitters.No harm or injury was reported.They will be sending this org in for a repair.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: 4 transmitters were used in conjunction with the cns, and are not the devices that experienced failure.Attempts to obtain the following information were made, but not provided: bsm - model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that the multiple patient receiver (org) started displaying signal loss for 4 transmitters.

Manufacturer Narrative

Details of complaint: the customer reported that the multiple patient receiver (org) started displaying signal loss for 4 transmitters.They sent the unit in for evaluation and repair.No patient harm was reported.Service requested / performed: evaluation / repair.Investigation summary: nihon kohden repair center (nk rc) was not able to duplicate the issue of communication loss.The org was exchanged in ticket 102933 to resolve the issue.The root cause for this issue is likely related to environmental factors combined with normal wear and tear due to the age of the device.It was installed at the customer's facility in 06/2010.As the device was evaluated and found to be in good working order, the issue of signal loss is unlikely related to a design or manufacturing deficiency of an nk device.A capa is not warranted.Additional device information: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Telemetry transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the multiple patient receiver (org) started displaying signal loss for 4 transmitters.

• 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: 10289807
• MDR Text Key: 200638863
• Report Number: 8030229-2020-00393
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/17/2020,06/16/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2020
• Distributor Facility Aware Date: 06/24/2020
• Device Age: 125 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 06/06/2020
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2010
• 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: 4 TRANSMITTERS; 4 TRANSMITTERS; CNS