MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bse) reported that the multiple patient receiver (org) is sending intermittent signal loss on the device(s) being monitored.No patient harm was 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.Attempt # 1: 08/05/2021 emailed the customer via microsoft outlook for information: no reply was received.Attempt # 2: 08/26/2021 emailed the customer via microsoft outlook for information: no reply was received.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is sending intermittent signal loss on the device(s) being monitored.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is sending intermittent signal loss on the device(s) being monitored.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bse) reported that the multiple patient receiver (org) is sending intermittent signal loss on the device(s) being monitored.No patient harm was reported.Nihon kohden technical support advised the customer that there may have been a signal interference from the rssi values they reported.Investigation summary: signal loss can occur due to other equipment using the same frequency range or battery losing charge.The customer reported at a later date that the issue of intermittent signal loss was resolved without any rework or intervention and that they did testing on the transmitters and the system and are not getting any more signal loss.As such, root cause for the intermittent signal loss is most likely related to environmental factors.There is no evidence of an nk device malfunction since no similar complaint of this type have been received after this report, therefore, a corrective action/preventative action (capa) is not warranted.Attempt # 1: 08/05/2021 emailed the customer via microsoft outlook for information: no reply was received.Attempt # 2: 08/26/2021 emailed the customer via microsoft outlook for information: no reply was received.

• Brand Name: ORG-9100A
• 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: 12378234
• MDR Text Key: 268514054
• Report Number: 8030229-2021-01565
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 06/10/2022

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-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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; CNS; TELEMETERS; TELEMETERS; CNS; TELEMETERS