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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 Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
The customer reported that gz is dropping off randomly.The patients have been switched to bsm-1700 transport till issue is resolved.There was no patient injury 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.
 
Event Description
The customer reported that the gz monitor is dropping off randomly.There was no patient injury 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 Key12170457
MDR Text Key281750396
Report Number2080783-2021-00403
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 07/13/2021,07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2021
Distributor Facility Aware Date06/15/2021
Device Age35 MO
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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