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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 Radio Signal Problem (1511); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2017
Event Type  malfunction  
Manufacturer Narrative
The biomedical engineer reported that the org experienced signal loss on 3 of the 5 channels. After speaking to the repair center, the customer decided to not send in the unit and take care of the issue on their own.
 
Manufacturer Narrative
The biomedical engineer reported that the org experienced signal loss on 3 of the 5 channels. After extensive troubleshooting, the biomedical engineer decided to send the unit in for repair. Nihon kohden is currently waiting for the unit to be returned. The unit was in use on patients, but no patient harm was 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 biomedical engineer reported that the org experienced signal loss on 3 of the 5 channels.
 
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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, 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
MDR Report Key6831670
MDR Text Key264829980
Report Number8030229-2017-00284
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 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2017
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA08/30/2017
Distributor Facility Aware Date08/06/2017
Device Age53 MO
Event Location Hospital
Date Report to Manufacturer08/30/2017
Date Manufacturer Received08/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2013
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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