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 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant 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.Additional device information: concomitant medical device: the zm-531pa and zm-541pa telemetry transmitters were being used in conjunction with the org, but no serial numbers were provided by the customer.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant signal loss.No patient harm reported.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) failed and 8 telemetry transmitter are in constant signal loss.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) failed, and 8 telemetry transmitters were in constant signal loss.The unit was sent in for evaluation and repair.Service requested / performed: evaluation and repair.Investigation summary: nihon kohden repair center (nk rc) evaluated the reported device and was able to duplicate the issue of signal loss.This was found to be caused by the ip scheme the customer was using.When changed to a different ip scheme, the field signal strength was stronger and signal loss did not occur.As such, the signal loss is unlikely to be related to nk device malfunction but rather the customer's network environment.

• 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: 10348547
• MDR Text Key: 201571157
• Report Number: 8030229-2020-00417
• 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: 07/30/2020,01/23/2023

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: 07/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2020
• Distributor Facility Aware Date: 07/06/2020
• Device Age: 124 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/23/2023
• 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: TELEMETRY TRANSMITERS ZM-531PA; TELEMETRY TRANSMITERS ZM-541PA; ZM-531PA; ZM-541PA