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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER

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NIHON KOHDEN CORPORATION ORG-9100A MULTIPLE PATIENT RECEIVER Back to Search Results
Model Number ORG-9100A
Device Problems Communication or Transmission Problem (2896); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
The customer's it personnel reported that the org manifested problems resulting in communication loss on all channels. Nihon kohden technical support provided troubleshooting support and advised the customer to re-establish communication with the transmitters on the cns. One of the devices had a "communication error" so he was advised to power cycle the org. All of the channels then came up showing "communication loss. " the customer was provided with a loaner and sent the org in to nihon kohden for repair. The device has been received and will undergo evaluation. 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 customer's it personnel reported that the org manifested problems resulting in communication loss on all channels.
 
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Brand NameORG-9100A
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, 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 Key7419453
MDR Text Key105287843
Report Number8030229-2018-00104
Device Sequence Number1
Product Code DRG
UDI-Device Identifier04931921103883
UDI-Public04931921103883
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9100A
Device Catalogue NumberORG-9100A
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/21/2019
Distributor Facility Aware Date10/07/2019
Device Age114 MO
Event Location Hospital
Date Report to Manufacturer10/21/2019
Date Manufacturer Received10/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNOT APPLICABLE

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