UNKINVOS UNSPECIFIED INVOS PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for UNKINVOS UNSPECIFIED INVOS PRODUCT manufactured by Jabil Circuit (shanghai) Ltd.

Event Text Entries

[142865353] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[142865354] According to the reporter, the nurse noted that there was slight pressure injury from the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2019-00305
MDR Report Key8542144
Date Received2019-04-23
Date of Report2019-04-23
Date Mfgr Received2019-04-04
Date Added to Maude2019-04-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1JABIL CIRCUIT (SHANGHAI) LTD
Manufacturer StreetNO 600 TIAN LIN ROAD
Manufacturer CitySHANGHAI,20 200233
Manufacturer CountryCN
Manufacturer Postal Code200233
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKINVOS
Product CodeQEM
Date Received2019-04-23
Model NumberUNSPECIFIED INVOS PRODUCT
Catalog NumberUNSPECIFIED INVOS PRODUCT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerJABIL CIRCUIT (SHANGHAI) LTD
Manufacturer AddressNO 600 TIAN LIN ROAD SHANGHAI,20 200233 CN 200233


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-23

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