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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 Problem Patient Data Problem (3197)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2023
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.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.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: a2: a6.B6: b7.D10: attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: (b)(6 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
 
Event Description
The biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.
 
Manufacturer Narrative
Incident summary: the biomedical engineer (bme) reported that this unit will intermittently stop transmitting ecg electrocardiogram waves to the cns while in use on a patient.No patient harm was reported.The biomed placed this unit on a simulator and watched it occur where the ecg waves went to flat line on the cns then came back.The bme confirmed this also occurred on the transmitter as well, they tried different leads as well issue but the issue still occurred.Biomed is sending the unit into nihon kohden repair center.Investigation summary: multiple follow-up requests regarding the return of the device were made to the customer, but the customer has been unresponsive to the phone call messages and emails sent for the return of this device.A definitive root cause could not be determined since we have not received the device for evaluation.Possible cause may include hardware component failure due to physical damage or fluid intrusion from user mishandling, electrical damage from improper battery usage, or wear-and-tear which depends on device age and frequency of use.Review of the complaint device's serial number does not show other complaints.The complaint could not be confirmed as we have not received the device after multiple follow-up requests.Nk will continue to monitor and trend similar complaints.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 12/28/2023 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 01/12/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 01/18/2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.
 
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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
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key18540550
MDR Text Key333548513
Report Number8030229-2024-04029
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/23/2024
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 12/26/2023
Initial Date FDA Received01/18/2024
Supplement Dates Manufacturer Received04/19/2024
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2022
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
CNS.; CNS.
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