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 TOMIOKA CORPORATION ZM-531PA; 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 TOMIOKA CORPORATION ZM-531PA; TRANSMITTER Back to Search Results
Model Number ZM-531PA
Device Problems Overheating of Device (1437); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/19/2015
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter functions intermittently and is excessively hot when in use.Device turns off by itself and when batteries are changed the problem stays the same.When it does function, the waveform is very distorted.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.There was sign of corrosion on the battery contact in the battery housing of rear case assembly.Some kind of sticky residue in the socket of center case and had scratches on lcd screen cover.Cleaned the unit and replaced parts to meet manufacturer's specification.The device returned by the customer was not sent back after repair as nihon kohden exchanged the device with another transmitter.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 transmitter functions intermittently and is excessively hot when in use.Device turns off by itself and when batteries are changed the problem stays the same.When it does function, the waveform is very distorted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZM-531PA
Type of Device
TRANSMITTER
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
tomioka city, japan 370-2 343
JA  370-2343
Manufacturer (Section G)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
tokyo, japan 161-8 560
JA   161-8560
Manufacturer Contact
thomas bento
1-31-4 nishiochia, shinjuku-ku
tokyo, japan 161-8-560
JA   161-8560
2687708
MDR Report Key5241824
MDR Text Key31789590
Report Number8030229-2015-00390
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/18/2015,10/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2015
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 Manufacturer10/23/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2015
Distributor Facility Aware Date10/19/2015
Event Location Hospital
Date Report to Manufacturer11/18/2015
Date Manufacturer Received11/18/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-