MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Output Problem (3005)

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

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.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 telemetry transmitter: central nurse's station, model: cns-6801a, sn: (b)(4).

Event Description

The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.No patient harm reported.

Manufacturer Narrative

Details of complaint: the customer reported that a gz-120pa transmitter had a patient name disappear from the cns tile, however, the vitals were still present.The cns was monitoring a gz transmitter and when the nurse re-entered the id, the patient showed up again.Service requested / performed: troubleshooting.Investigation summary: if the reported malfunction were to recur and the patient's name and patient id disappeared from the tile, it could cause confusion and delay of patient treatment in the case of an event.The reported event would be likely to cause or contribute to death or serious injury if a patient event were missed.The root cause of this issue cannot be determined as there was not enough information provided from the customer.Attempts to obtain further information were made, however, the customer was unresponsive.The overall risk rating is medium.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the transmitter: central nurse's station: model #: cns-6801a; serial #: (b)(6); device manufacturer data: dd/mm/yyyy; unique identifier (udi) #: (b)(4); returned to nihon kohden: dd/mm/yyyy.

Event Description

The clinical informatics nurse reported that the patient name and patient id disappeared from the central nurse's station (cns) patient tile but the vitals remained.The patient was being monitored on a telemetry transmitter.This only happened with this transmitter once.Then the nurse re-entered the patient id and the patient name came back on the tile.At this point, they are not having the issue, and this seems to be isolated incident at this time.No patient harm reported.

• Brand Name: GZ-120PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• MDR Report Key: 10463383
• MDR Text Key: 204765400
• Report Number: 8030229-2020-00475
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (y/n): N
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2020,05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2020
• Distributor Facility Aware Date: 07/28/2020
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS-6801A SN (B)(6).; CNS-6801A SN (B)(6).