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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-9100A
Device Problems Alarm Not Visible (1022); No Display/Image (1183); Communication or Transmission Problem (2896); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the device was having an issue with not showing extended alarms. In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss. Patients were moved to another device. 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 device was having an issue with not showing extended alarms. In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss. Patients were moved to another device.
 
Manufacturer Narrative
The customer reported that the device was having an issue with not showing extended alarms. In an effort to correct the issue the biomedical engineer attempted to reboot the device and the device came back on with a red error light and all patients went into communication loss. Patients were moved to another device. The unit was evaluated and the error light was confirmed during 2 weeks of extended testing. The main pcb was replaced to resolve the issue. All steps in the maintenance check sheet of service manual were completed and the unit performed one more day of extended testing with the cns. The unit was configured but the channels will need to be input by the customer. The device has been repaired and returned to the customer. 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-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
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 Key5728279
MDR Text Key48333619
Report Number8030229-2016-00261
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 06/15/2016,05/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2016
Distributor Facility Aware Date05/16/2016
Device Age10 MO
Event Location Hospital
Date Report to Manufacturer06/15/2016
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2015
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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