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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT

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NIHON KOHDEN CORPORATION ORG-9700A RECEIVER UNIT Back to Search Results
Model Number ORG-9700A
Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that there was telemetry dropout for two of the beds on the org. The rssi level when the device was turned off was reading at 6-7. The device was rebooted but the problem still remained. A loaner was sent to the customer. The customer reported that when the loaner was installed, two of the patient tiles that had patients being monitored changed as if they were available to admit and two other patient tile names were different. It is unknown how the tile changed occured. Customer was asked to verify the model of the org and cns software version as there was some miscommunication as to correct model and software version of both the cns and org. Customer verified that the defective model was the org-9700. Once verified the customer was asked to reboot the cns (central monitoring station) with the loaner org and track any signal loss and duplicate channel issues. Rebooting the cns did not resolve the issue. A spectrum analysis of the facility is being setup. The product involved in this event has not been returned to date to allow for an analysis to be performed. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if the product is returned for evaluation or new information is obtained.
 
Event Description
The customer reported that there was telemetry dropout for two of the beds on the org. The rssi level when the device was turned off was reading at 6-7. The device was rebooted but the problem still remained. A loaner was sent to the customer.
 
Manufacturer Narrative
Manufacturer narrative: the customer reported that there was telemetry dropout for two of the beds on the org. The rssi level when the device was turned off was reading at 6-7. The device was rebooted but the problem still remained. A loaner was sent to the customer. The customer reported that when the loaner was installed, two of the patient tiles that had patients being monitored changed as if they were available to admit and two other patient tile names were different. It is unknown how the tile changed occurred. Customer was asked to verify the model of the org and cns software version as there was some miscommunication as to correct model and software version of both the cns and org. Customer verified that the defective model was the org-9700. Once verified the customer was asked to reboot the cns (central monitoring station) with the loaner org and track any signal loss and duplicate channel issues. Rebooting the cns did not resolve the issue. A spectrum analysis of the facility is being setup. The product involved in this event has not been returned to date to allow for an analysis to be performed. The unit was evaluated and the problem was duplicated. Three of the 8 receivers are bad, unfortunately, the parts needed to repair are obsolete. Slot 3,4,&5 have an rssi level of zeros and ones. The org has been returned to the customer without repair as the customer wanted to get new org and keep the old parts until they are useless. Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803. 56 if additional information becomes available.
 
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Brand NameORG-9700A
Type of DeviceRECEIVER UNIT
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
486 nanokaichi
attn: shama mooman
gunma 370-2 343
JA 370-2343
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 Key5582418
MDR Text Key43476503
Report Number8030229-2016-00165
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 04/15/2016,03/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9700A
Device Catalogue NumberMU-970RA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/15/2016
Distributor Facility Aware Date03/16/2016
Device Age96 MO
Event Location Hospital
Date Report to Manufacturer04/15/2016
Date Manufacturer Received04/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2008
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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