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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 No Device Output (1435); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the gz telemetry transmitter (tele) does not show the hr values and waveforms.They tested on a simulator, and the issue is duplicated.Qa inquired whether there was an error message of it failing, whether the parameter was in use when it failed or whether the staff went to use the parameter and found it did not work.The customer has been unresponsive to the inquiries.No patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer (bme) reported that the gz telemetry transmitter (tele) does not show the hr values and waveforms.They tested on a simulator, and the issue is duplicated.Qa inquired whether there was an error message of it failing, whether the parameter was in use when it failed or whether the staff went to use the parameter and found it did not work.The customer has been unresponsive to the inquiries.No patient harm was 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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device section.No reply was received.Central nurse's station model: ni sn:(b)(6) device manufacturer date: ni unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned.
 
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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 Key18540751
MDR Text Key333512026
Report Number8030229-2024-04042
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
Report Date 01/18/2024
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 12/20/2023
Initial Date FDA Received01/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2017
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
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