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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 Problem Wireless Communication Problem (3283)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org, multiple patient receiver has intermittent signal loss on 4 channels. Customer was sent a loaner device. The device was sent in for evaluation. The unit was cleaned and evaluated. The reported problem of intermittent signal loss on 4 channels was duplicated. The unit also had noise artifact on all receivers. All eight receivers were replaced on this unit with the newest version. The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet. The unit was tested and operates to manufacturer's specifications. 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 the org, multiple patient receiver has intermittent signal loss on 4 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, 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 Key6520983
MDR Text Key73670591
Report Number8030229-2017-00117
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 04/25/2017,11/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
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 Manufacturer11/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/25/2017
Distributor Facility Aware Date11/01/2016
Device Age45 MO
Event Location Hospital
Date Report to Manufacturer04/25/2017
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2013
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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