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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the org had signal loss on all transmitters. The biomedical engineer tried changing the group and unmonitoring an old monitor, and then remonitored it, however the issue continued to persist. The device was not in use on patients at the time. 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 biomedical engineer reported that the org had signal loss on all transmitters.
 
Manufacturer Narrative
Manufacturer narrative: the biomedical engineer reported that the org had signal loss on all transmitters. The biomedical engineer tried changing the group, un-monitoring an old monitor, and then remonitored it, however the issue continued to persist. The device was not in use on patients at the time. In further troubleshooting this issue, it was later determined that this was not a malfunction of the device, but considered to be a use error event. The default channels on the org were still selected. Once the channels were properly set, monitoring resumed, resolving the issue. 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.
 
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Brand NameORG-9100A
Type of DeviceMULTIPLE PATIENT RECEIVER
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
attn: shama mooman
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
1-1 tajino
attn: shama mooman
tomioka city, gunma 370-2 314
JA 370-2314
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
2687488
MDR Report Key6414888
MDR Text Key70329862
Report Number8030229-2017-00077
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,Followup
Report Date 03/17/2017,02/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 FDA03/17/2017
Distributor Facility Aware Date02/17/2017
Device Age104 MO
Event Location Hospital
Date Report to Manufacturer03/17/2017
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2008
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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