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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 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the transmitter heated up when being used on a patient but there was no patient harm or incident. The bme tested the unit and could not replicate the overheating. An exchange device was sent to the customer and the transmitter was returned to nihon kohden for evaluation. It is pending qa investigation. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
 
Event Description
The biomedical engineer reported that the transmitter heated up when being used on a patient but there was no patient harm or incident.
 
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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 Key7708476
MDR Text Key114679929
Report Number8030229-2018-00275
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 Biomedical Engineer
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 Received07/21/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2019
Distributor Facility Aware Date08/20/2019
Device Age91 MO
Event Location Hospital
Date Report to Manufacturer08/21/2019
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2010
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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