ACROBAT-I STABILIZER 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,foreig report with the FDA on 2020-01-02 for ACROBAT-I STABILIZER OM-10000 manufactured by Maquet Cardiovascular Llc.

Event Text Entries

[188398027] 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


[188398028] The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer knob was rotating continuously and was not able to tighten. 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 Number2242352-2020-00010
MDR Report Key9539490
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-02
Date of Report2019-12-31
Date of Event2019-12-10
Date Mfgr Received2019-12-10
Device Manufacturer Date2019-04-26
Date Added to Maude2020-01-02
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 Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer G1MAQUET CARDIOVASCULAR LLC
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal Code07470
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACROBAT-I STABILIZER
Generic NameSTABILIZER, HEART
Product CodeMWS
Date Received2020-01-02
Model NumberOM-10000
Catalog NumberOM-10000
Lot Number25146301
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOVASCULAR LLC
Manufacturer Address45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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