OM-10000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-08 for OM-10000 manufactured by Maquet (suzhou) Co.,ltd..

Event Text Entries

[188404307] Trackwise id #(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr? S for the reported lot number. The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received.
Patient Sequence No: 1, Text Type: N, H10


[188404308] The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer suction connector broke off upon connecting. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2242352-2020-00033
MDR Report Key9566221
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-08
Date of Report2020-03-06
Date of Event2019-12-17
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-08-16
Date Added to Maude2020-01-08
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 StreetNO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK
Manufacturer CitySUZHOU
Manufacturer CountryUS
Manufacturer G1MAQUET (SUZHOU) CO.,LTD.
Manufacturer StreetNO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK
Manufacturer CitySUZHOU
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOM-10000
Generic NameSTABILIZER, HEART
Product CodeMWS
Date Received2020-01-08
Returned To Mfg2020-01-09
Model NumberOM-10000
Catalog NumberOM-10000
Lot Number25147609
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET (SUZHOU) CO.,LTD.
Manufacturer AddressNO.158 FANG ZHOU ROAD SUZHOU INDUSTRIAL PARK SUZHOU US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-08

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