ORG-9110A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-02 for ORG-9110A manufactured by Nihon Kohden Corporation.

Event Text Entries

[181770243] The customer reported that their multiple patient receiver (org) was displaying communication loss for 8 transmitters. Nk ts advised the customer to check the org closet and see if the org was powered off or had an error light blinking. The customer then reported that there was an error light that was blinking on the org. Nk ts instructed them to power off this org, but the issue persisted. The customer will be sending this unit in for a repair. 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. Additional model information: 8 transmitters were used in conjunction with the org and are not the devices that experienced failure. Attempts to obtain the following information were made, but not provided: transmitters - model: n,i s/n: ni, approximate age of the device: no serial number was provided, so the age of the device is unknown. Device manufacturer date: ni, unique identifier (udi) #: ni.
Patient Sequence No: 1, Text Type: N, H10


[181770244] The customer reported that their multiple patient receiver (org) was displaying communication loss for 8 transmitters.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8030229-2020-00139
MDR Report Key9777605
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-02
Date of Report2020-03-02
Date of Event2020-02-20
Date Facility Aware2020-02-20
Report Date2020-03-02
Date Reported to FDA2020-03-02
Date Reported to Mfgr2020-03-02
Date Mfgr Received2020-02-20
Device Manufacturer Date2013-04-18
Date Added to Maude2020-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHAMA MOOMAN
Manufacturer StreetSAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2
Manufacturer CityKUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8580
Manufacturer CountryJA
Manufacturer Postal359-8580
Manufacturer G1NIHON KOHDEN TOMIOKA CORPORATION
Manufacturer Street1-1 TAJINO ATTN: SHAMA MOOMAN
Manufacturer CityTOMIOKA CITY, 370-2314
Manufacturer CountryJA
Manufacturer Postal Code370-2314
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameORG-9110A
Generic NameMULTIPLE PATIENT RECEIVER
Product CodeDRG
Date Received2020-03-02
Model NumberORG-9110A
Catalog NumberORG-9110A
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age82 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIHON KOHDEN CORPORATION
Manufacturer Address1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN TOKYO, 161-8560 JA 161-8560


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-02

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