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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 Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/20/2021
Event Type  malfunction  
Event Description
The biomedical engineer reported that the telemetry transmitter only reads one ecg lead.The customer has tried different leads, and the issue persisted.There was no error message displayed on the central nurse's station (cns) that was monitoring this unit.No patient harm was reported.
 
Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter only reads one ecg lead.The customer has tried different leads, and the issue persisted.There was no error message displayed on the central nurse's station (cns) that was monitoring this unit.No patient harm was 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
MDR Report Key12493567
MDR Text Key282296454
Report Number2080783-2021-01717
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921117415
UDI-Public04931921117415
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2021
Distributor Facility Aware Date08/20/2021
Device Age54 MO
Event Location Hospital
Date Report to Manufacturer09/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CNS-6801A SN (B)(4)
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