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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER Back to Search Results
Model Number ZM-530PA
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the telemetry transmitter got hot and they smelled smoke coming from the unit.Them the unit turned off and would not turn on again.This occurred at the set-up stage before being put into patient use.No harm or injury reported.
 
Event Description
The biomedical engineer reported that the telemetry transmitter got hot and they smelled smoke coming from the unit.Them the unit turned off and would not turn on again.This occurred at the set-up stage before being put into patient use.No harm or injury reported.
 
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Brand Name
ZM-530PA
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 Key11255297
MDR Text Key246743409
Report Number2080783-2021-00037
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115091
UDI-Public4931921115091
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-530PA
Device Catalogue NumberZM-530PA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2021
Distributor Facility Aware Date12/30/2020
Device Age80 MO
Event Location Hospital
Date Report to Manufacturer01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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