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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN TOMIOKA CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Wireless Communication Problem (3283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
The bme reported that the org gave a sawtooth waveform on multiple devices. Five follow-up attempts were made to the customer for additional information, however no further information was made available to nihon kohden on the event. 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 org gave a sawtooth waveform on multiple devices.
 
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Brand NameORG-9100A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA 370-2314
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: susan shadley
tomioka city, japan 370-2 314
JA 370-2314
Manufacturer Contact
susan shadley
1-31-4 nishiochiai, shinjuku-k
attn: susan shadley
tokyo, japan 161-8-560
JA   161-8560
2687133
MDR Report Key6298977
MDR Text Key66459029
Report Number8030229-2017-00019
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071058
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 02/02/2017,01/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/02/2017
Distributor Facility Aware Date01/04/2017
Device Age0 MO
Event Location Hospital
Date Report to Manufacturer02/02/2017
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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