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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION MEB-9400A; ELECTROMYOGRAPH
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NIHON KOHDEN CORPORATION MEB-9400A; ELECTROMYOGRAPH Back to Search Results
Model Number MEB-9400A
Device Problems Temperature Problem (3022); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury reported.
 
Event Description
The customer reported that there was a burning smell from the power supply from their meb-9400a system after it had shutdown.They got it running for a little while in safe mode and would like the system evaluated.However, they have ordered a replacement and are awaiting its arrival before taking this unit offline.The caller and their it person expressed they wanted to keep the system in use after i explained the system may be a hazard to the patients.No patient harm or injury reported.
 
Manufacturer Narrative
Complaint details: the customer reported on (b)(6) 2018 that they were getting burning smell from power supply.The system had shut down.The customer got it running for a little while in safe mode but wanted it to be checked out.Service requested: the customer requested the device to be evaluated service provided: the customer did not send in the unit for repair/evaluation investigation result: the unit was placed into service on (b)(6) 2017, which is over 1 year at the time of the reported issue.A review of device history found no previously reported similar issue with this device.Similar tickets using "meb 9400a burning smell power supply" and gave no result.Review of tickets reported by the neurological medicine found no similar reported issue.Based on the device service history, complaints from customer site and similar search query, no adverse trend is suspected with the device.The root cause of the issue was unable to be determined due to limited information in the complaint record and the device was not returned to nk for repair/evaluation.The customer was informed about the hazard that can occur to the patients.The device was being used by the customer.No further complaint was reported with the device.Corrected information: f9.Approximate age of device: incorrectly calcuated g4.Date received by manufacturer: should be (b)(6) 2018 not (b)(6) 2019 as listed on mdr initial report.
 
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Brand Name
MEB-9400A
Type of Device
ELECTROMYOGRAPH
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, 161-8 560
JA  161-8560
MDR Report Key8220327
MDR Text Key132513579
Report Number8030229-2019-00001
Device Sequence Number1
Product Code IKN
UDI-Device Identifier04931921102183
UDI-Public04931921102183
Combination Product (y/n)N
PMA/PMN Number
K010590
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMEB-9400A
Device Catalogue NumberMEB-9400A
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2019
Distributor Facility Aware Date11/01/2019
Device Age66 MO
Event Location Hospital
Date Report to Manufacturer11/06/2019
Date Manufacturer Received11/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT APPLICABLE
Patient Sequence Number1
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