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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 Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the org is dropping its signal on multiple channels. No consequence or impact to the patient was reported. During follow up with the customer, the customer indicated that the issue resolved by a software downgrade. 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 reported that the org is dropping its signal on multiple channels. No consequence or impact to the patient.
 
Manufacturer Narrative
On (b)(6) 2018 customer stated org receiver could not get a signal after a software downgrade. When later contacted, customer stated the issue was resolved but did not provide details of the resolution. Service requested: troubleshooting. Service performed: troubleshooting. Investigation result: device was put into service on 8/25/2012. This device does not have a history of signal loss. Service history for this customer shows one signal loss incident at around the same time, notification # (b)(4). Under this notification, customer stated there was recent construction activity at the facility. Customer's third-party vendor had moved the antenna system during construction. This system was later reinstalled. Construction activities could cause a wireless signal interference. Further, re-installation of the antenna system could also cause performance issues. A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device. Please see attached dhr review form. Due to customer stating that the issue had resolved, and no information could be provided, the root cause of the reported issue could not be determined. Customer's service history shows this issue has not re-occurred since this (b)(6) 2018.
 
Event Description
The customer reported that the org is dropping its signal on multiple channels. No consequence or impact to the patient.
 
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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, 161-8 560
JA 161-8560
MDR Report Key8198077
MDR Text Key131500510
Report Number8030229-2018-00496
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
PMA/PMN Number
K071058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberORG-9110A
Device Catalogue NumberORG-9110A
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2019
Distributor Facility Aware Date07/22/2019
Device Age106 MO
Event Location Hospital
Date Report to Manufacturer07/22/2019
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNOT APPLICABLE

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