Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER Back to Search Results
Model Number ZM-530PA
Device Problems Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that a patient stated that they were shocked by the telemetry transmitter.The biomed stated that there was no harm to the patient and that it was a minor shock.No signs of physical damage.No signs of fluid intrusion.No patient harm reported.
 
Event Description
The biomedical engineer reported that a patient stated that they were shocked by the telemetry transmitter.The biomed stated that there was no harm to the patient and that it was a minor shock.No signs of physical damage.No signs of fluid intrusion.No patient harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11572199
MDR Text Key280475638
Report Number2080783-2021-00169
Device Sequence Number1
Product Code DRT
UDI-Device Identifier04931921115091
UDI-Public4931921115091
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2021
Distributor Facility Aware Date02/23/2021
Device Age105 MO
Event Location Hospital
Date Report to Manufacturer03/25/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CENTRAL NURSE'S STATION
-
-