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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 Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org had complete signal loss. Replacing the unit with another known good org resolved the signal loss. The customer sent the failed unit in for evaluation and repair. The unit was cleaned and evaluated. The reported problem of communication loss with the network was not duplicated through testing, troubleshooting, or extended operation of the device. Review of the device history indicates no previous cnd status. The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet. The unit operates to manufacturer's specifications. 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 customer reported that the org had complete signal loss.
 
Manufacturer Narrative
The customer reported that the org had complete communication loss with the telemetry monitors. The charge nurse reported that they could not see the patients on the monitors. The facility's clinical engineering (ce) was able to establish communication with all telemetry monitors after about 15 minutes. They then went down again for about 15 minutes, then again 48 minutes later. Clinical engineering (ce) was then able to get the monitors up on the floor itself. Replacing the unit with another known good org resolved the signal loss. The customer sent the failed unit in for evaluation and repair. The unit was cleaned and evaluated. The reported problem of communication loss with the network was not duplicated through testing of more than 72 hours, troubleshooting, or extended operation of the device. All receivers were tested with a transmitter and central nurse's station (cns). Full disclosure was reviewed to ensure there was no communication loss. Review of the device history indicates no previous cnd status. The unit was tested per the operator's manual and the results were recorded on the maintenance check sheet. The unit operates to manufacturer's specifications. 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-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 Key6324449
MDR Text Key67263125
Report Number8030229-2017-00038
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 02/10/2017,01/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2017
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 Manufacturer01/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2017
Distributor Facility Aware Date01/09/2017
Device Age83 MO
Event Location Hospital
Date Report to Manufacturer02/10/2017
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2010
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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