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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER Back to Search Results
Model Number ZM-531PA
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
The biomedical engineer (bme) reported that the transmitter became very hot while the nurses were setting it up to be put on a patient.The nurses removed the batteries.The biomed tested it in their shop, and the transmitter did become extremely hot.They can see where the case was starting to melt, and they have indicated they are using the same (b)(6) batteries they always use.However, for some reason, this unit is overheating.This was not in patient use and no harm reported.
 
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Brand Name
ZM-531PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
attn: shama mooman
1-31-4 nishiochia
shinjuku-ku, tokyo 161-8 560
JA  161-8560
MDR Report Key12866444
MDR Text Key285474724
Report Number2080783-2021-01992
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115107
UDI-Public04931921115107
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 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-531PA
Device Catalogue NumberZM-531PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2021
Distributor Facility Aware Date10/25/2021
Device Age78 MO
Event Location Hospital
Date Report to Manufacturer11/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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