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

Model Number GZ-120PA

Device Problems Computer Software Problem (1112); Loss of Data (2903); Data Problem (3196); Patient Data Problem (3197); Patient Device Interaction Problem (4001)

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

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

The clinical informatics nurse reported that the patients are getting discharged from the telemetry transmitter and all the data is getting deleted from it.We are not sure if the transmitters are discharging themselves, or if this is an user error where the control buttons are not locked and preventing the discharge of the unit when the patient rolls or touches the unit, or if this is an user error where someone is discharging the patient by accident.The logs are being collected for investigation.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 gz telemetry transmitter.Central nurse's station, model: cns-6801a, sn: (b)(4).

Event Description

The clinical informatics nurse reported that the patients are getting discharged from the telemetry transmitter and all the data is getting deleted from it.We are not sure if the transmitters are discharging themselves, or if this is an user error where the control buttons are not locked and preventing the discharge of the unit when the patient rolls or touches the unit, or if this is an user error where someone is discharging the patient by accident.The logs are being collected for investigation.No patient harm reported.

Manufacturer Narrative

Details of complaint: the clinical informatics nurse reported that patients were getting discharged from the telemetry transmitter and all data was deleted.No patient harm or injury was reported.Investigation summary: in a follow-up with the customer, it was identified that the patients were getting discharged from the tiles and that the data is missing / deleted.It is unknown if the transmitters were discharging on their own or if the transmitters were accidentally being discharged.When a discharge occurred, all patient data was deleted from the device.If the gz is locally filed into a cns, the data is stored on the cns for 120 hours (5 days) before the data is removed from the cns.Based on the available information, a definitive root cause could not be identified.It is possible that the device was accidentally being discharged due to the screen not being locked.If the screen is not locked, the patient's movements may cause actions on the screen of the device to be triggered and may lead to discharging of the device.Improvements were made on the lock screen functionality of the gz device to have it start on a locked screen.Per (b)(4), the version update to v02-22 (complaint devices are in an earlier version, v02-20) added a mode to start with a locked screen when the gz starts.Additionally, when the gz starts up, the key lock state at the time of the previous power off is continued.

Event Description

The clinical informatics nurse reported that the patients are getting discharged from the telemetry transmitter and all the data is getting deleted from it.We are not sure if the transmitters are discharging themselves, or if this is an user error where the control buttons are not locked and preventing the discharge of the unit when the patient rolls or touches the unit, or if this is an user error where someone is discharging the patient by accident.The logs are being collected for investigation.No patient harm reported.

• Brand Name: GZ-120PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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: 10121470
• MDR Text Key: 195002201
• Report Number: 8030229-2020-00305
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/04/2020,02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2020
• Distributor Facility Aware Date: 05/13/2020
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2020
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2019
• 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-6801A SN (B)(6); CNS-6801A SN (B)(6); CNS-6801A (B)(4)