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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER Back to Search Results
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.
 
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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 Key11325613
MDR Text Key266600321
Report Number8030229-2021-00070
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921117415
UDI-Public04931921117415
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153707
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGZ-130PA
Device Catalogue NumberGZ-130PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2021
Initial Date FDA Received02/12/2021
Supplement Dates Manufacturer Received05/08/2023
Supplement Dates FDA Received05/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)
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