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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA

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NIHON KOHDEN CORPORATION ZM-930PA Back to Search Results
Model Number ZM-930PA
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter became hot. The nurse removed the unit to investigate and found one of the procell batteries had began to peel. The biomedical engineer replaced the batteries and tested the unit for one week and found no issues. The unit was not returned for further analysis as the biomedical engineer determined that the incident occurred as a result of a bad battery.
 
Event Description
The customer reported that the transmitter became hot.
 
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Brand NameZM-930PA
Type of DeviceZM-930PA
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
attn: shama mooman
tomioka city, 370-2 343
JA 370-2343
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
kusunokidai tokorozawa, saitama 359-8-580
JA   359-8580
MDR Report Key7695257
MDR Text Key114331379
Report Number8030229-2018-00268
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZM-930PA
Device Catalogue NumberZM-930PA
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2019
Distributor Facility Aware Date05/09/2019
Device Age131 MO
Event Location Hospital
Date Report to Manufacturer08/21/2019
Date Manufacturer Received08/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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