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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9110A
Device Problems No Display/Image (1183); Radio Signal Problem (1511); Invalid Sensing (2293); Device Sensing Problem (2917)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected data: device evaluated by manufacturer, additional manufacturer narrative, additional information: type of report? follow up, type of report follow up, additional information/correction, event problem and evaluation codes. The biomedical engineer reported that the org experienced signal loss on multiple channels and had spikes on the spo2 waveform. It was confirmed that the revision of the receivers was too low and should be upgraded from rev ad to rev af or higher to resolve the issue. The unit was in use on patients but no patient harm was reported. The biomedical engineer sent the unit in for repair and the unit has been evaluated. The reported problem of spikes on the spo2 waveform and disappearing values were duplicated. All malfunctioning parts were replaced. The unit was tested per the operator's/service manual and the unit completed extended testing and operates to manufacturer's specifications.
 
Manufacturer Narrative
The biomedical engineer reported that the org experienced signal loss on multiple channels and had spikes on the spo2 waveform. It was confirmed that the revision of the receivers was too low and should be upgraded from rev ad to rev af or higher to resolve the issue. The unit was in use on patients, but no patient harm was reported. The biomedical engineer sent the unit in for repair and it is currently awaiting evaluation. 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 experienced signal loss on multiple channels and had spikes on the spo2 waveform.
 
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Brand NameORG-9110A
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
370-2 314
JA 370-2314
Manufacturer Contact
shama mooman
safety mgmt dept, quality mgmt
seibu bldg 2, 4th floor 1-11-2
JA   359-8580
MDR Report Key6715056
MDR Text Key257720148
Report Number8030229-2017-00232
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103906
UDI-Public04931921103906
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 07/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA07/14/2017
Distributor Facility Aware Date06/16/2017
Device Age58 MO
Event Location Hospital
Date Report to Manufacturer07/14/2017
Date Manufacturer Received07/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2012
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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