MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problems Application Program Problem (2880); Output Problem (3005)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz transmitter discharged and erased the patient information and the telemetry summary.The biomed tried working on the unit, but it continues to discharge the patient.The floor telemetry technician has to go into the patients room, take the battery out of the unit and remove the telemetry wires.At this time, they have 10 seconds to discharge the sector and then the telemetry tech installs the telemetry battery.Cmu then attempts to readmit the patient so that no heart rhythm information is lost.This process sometimes has to be repeated 2-3 times before the equipment will allow the sector to be readmitted.At 0226, the process was successful and the patient was readmitted.This malfunction is very frustrating for the 7 tower staff and the cmu staff.Not to mention that the device is not storing patient heart rhythm and / or spo2 information during this time.No patient harm reported.Nihon kohden continues to investigate the reported event.Central nurse's station (cns) model: ni.Sn: ni.

Event Description

The biomedical engineer reported that the gz transmitter discharged and erased the patient information and the telemetry summary.The biomed tried working on the unit, but it continues to discharge the patient.The floor telemetry technician has to go into the patients room, take the battery out of the unit and remove the telemetry wires.At this time, they have 10 seconds to discharge the sector and then the telemetry tech installs the telemetry battery.Cmu then attempts to readmit the patient so that no heart rhythm information is lost.This process sometimes has to be repeated 2-3 times before the equipment will allow the sector to be readmitted.At 0226, the process was successful and the patient was readmitted.This malfunction is very frustrating for the 7 tower staff and the cmu staff.Not to mention that the device is not storing patient heart rhythm and / or spo2 information during this time.No patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the gz transmitter was intermittently discharging and erasing patient information as well as the telemetry summary.During troubleshooting the bme was able to readmit the patient without losing the heart rhythm information.No patient harm was reported.Investigation summary: there is insufficient information to determine the cause of the discharging events.The procedures for admitting, discharging, and transferring are provided in the operator's manual for the device.The customer later provided two serial numbers for the cns: 947 and 1853.The service history for pu-621ra s/n (b)(6) shows this was recorded as an isolated incident.The service history for pu-621ra s/n (b)(6) shows no history of patient discharge events.The service history for this hospital shows no relevant events around the time of (b)(6) 2021.Approximately one year later, the customer reported an automatic discharge of a gz transmitter under ticket (b)(4).There was no resolution.The customer has not reported further events of patient discharge.The service history for this cns shows there is no recurrence history for this device.Additional information: b4 date of this report d8 was this device serviced by a third party? d1 brand name d4 model number catalog number serial number udi number g3 date received by manufacturer g4 pma / 510k number g6 type of report h2 if follow-up, what type? h4 device manufacture date h6 event problem and evaluation codes h10 additional manufacturer narrative additional device information: d10 concomitant medical device: the following devices were used in conjunction with the gz transmitter: central nurse's station (cns) model: pu-6201a sn: (b)(6) device manufacturer data: (b)(6) 2017 central nurse's station (cns) model: pu-6201a sn: (b)(6).Device manufacturer data: (b)(6) 2015.

Event Description

The biomedical engineer (bme) reported that the gz transmitter was intermittently discharging and erasing patient information as well as the telemetry summary.No patient harm reported.

• Brand Name: GZ-130PA
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11325613
• MDR Text Key: 266600321
• Report Number: 8030229-2021-00070
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)