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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER
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NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER Back to Search Results
Model Number ZM-521PA
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer (bme) reported that there was heat damage inside the battery well of the telemetry transmitter.This happened despite efforts to prevent the heat damage by ensuring fresh batteries and new contacts are used as often as possible.No patient harm was reported.
 
Event Description
The biomedical engineer (bme) reported that there was heat damage inside the battery well of the telemetry transmitter.This happened despite efforts to prevent the heat damage by ensuring fresh batteries and new contacts are used as often as possible.No patient harm was reported.
 
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Brand Name
ZM-521PA
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 Key12013557
MDR Text Key281146317
Report Number2080783-2021-00340
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115084
UDI-Public4931921115084
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberZM-521PA
Device Catalogue NumberZM-521PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2021
Distributor Facility Aware Date05/17/2021
Device Age35 MO
Event Location Hospital
Date Report to Manufacturer06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MULTIPLE PATIENT RECEIVER (ORG)
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