MANOSCAN RFG-3890

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-26 for MANOSCAN RFG-3890 manufactured by Given Imaging Los Angeles Llc.

Event Text Entries

[128246563] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[128246564] According to the reporter, when they attempted to extubate the patient, but the probe was stuck, and they had a difficulty removing it. They had to contact the ears, nose, throat (ent) department which took 2 hours. The catheter was in the patient's cricothyroid and they had to use a scope to check the location and remove it. The patient experience bleeding in the nasal cavity, but they were able to stop the bleeding and the patient was stable. They will not repeat the study. Technical support connected to the system and completed a search for the file but was still unable to find the study.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005344223-2018-00012
MDR Report Key8100693
Report SourceUSER FACILITY
Date Received2018-11-26
Date of Report2018-11-26
Date Mfgr Received2018-10-31
Date Added to Maude2018-11-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1GIVEN IMAGING LOS ANGELES LLC
Manufacturer Street5860 UPLANDER WAY
Manufacturer CityCULVER CITY CA 90230
Manufacturer CountryUS
Manufacturer Postal Code90230
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMANOSCAN
Generic NameSYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
Product CodeFFX
Date Received2018-11-26
Model NumberRFG-3890
Catalog NumberRFG-3890
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGIVEN IMAGING LOS ANGELES LLC
Manufacturer Address5860 UPLANDER WAY CULVER CITY CA 90230 US 90230


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-26

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