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

Model Number ORG-9100A

Device Problems Signal Artifact/Noise (1036); Connection Problem (2900); Incomplete or Inadequate Connection (4037)

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

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) had signal loss on three transmitters in three rooms in cpcu 2nd floor.Nurses reported signal loss at 12:49 am est on (b)(6) 2021.Patients were moved to different telemetry boxes.No patient harm or injury occurred.Customer will return device to nihon kohden.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.(b)(4).

Event Description

The biomedical engineer reported that the multiple patient receiver (org) had signal loss on three transmitters in three rooms in cpcu 2nd floor.Nurses reported signal loss at 12:49 am est on (b)(6) 2021.Patients were moved to different telemetry boxes.No patient harm or injury occurred.

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) had signal loss on three transmitters in three rooms in cpcu 2nd floor.Nurses reported signal loss at 12:49 am est on 04/17/2021.Patients were moved to different telemetry boxes.No patient harm or injury occurred.Customer will return device to nihon kohden.Service requested/performed: device was cleaned and decontaminated by nihon kohden america repair center (nka rc).The model, serial number and all labels were verified.On rc evaluation, were not able to duplicate the reported issue of signal loss.Device was tested by rc for a week and did not have any failures.Sent back to customer as is.Investigation summary: nka rc was not able to duplicate the reported issue of signal loss on this device.No physical damage was observed during evaluation.The customer reported that they were having issues with multiple org's at the time.This would indicate that the issue of signal loss is not isolated to one single device.It is likely that signal loss was occurring due to transmitter frequency issue.As such the root cause cannot be determined.As the issue of signal loss was not duplicated, a corrective action or preventative action is not warranted.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) had signal loss on three transmitters in three rooms in cpcu 2nd floor.Nurses reported signal loss at 12:49 am est on 04/17/2021.Patients were moved to different telemetry boxes.No patient harm or injury occurred.

• 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; 1-1 tajino; attn: shama mooman; 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: 11829103
• MDR Text Key: 252013264
• Report Number: 8030229-2021-00285
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• 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: ZM TRANSMITTERS; ZM TRANSMITTERS