VAVD CONTROLLER 70102.4459

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2015-01-29 for VAVD CONTROLLER 70102.4459 manufactured by Maquet Cardiopulmoary Ag.

Event Text Entries

[5396958] On (b)(6) 2011 (b)(6) reported that due to a handling error there was dried residue from a liquid in the pneumatic system of the vacuum controller (vavd) serial number (sn): (b)(4). It was requested that a repair quotation be sent before any repair was performed. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12899968] Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). Per service order (b)(4) the repair quotation was not accepted by the ssu and therefore the device was returned to the ssu without being repaired. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010762-2014-01030
MDR Report Key4461703
Report Source00,01,07
Date Received2015-01-29
Date of Report2011-10-12
Date of Event2011-09-30
Date Facility Aware2011-10-12
Report Date2011-10-12
Date Reported to Mfgr2011-10-12
Date Mfgr Received2011-10-12
Date Added to Maude2015-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTINA EVANCHO
Manufacturer Street45 BARBOUR POND DRIVE
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer Phone9737097265
Manufacturer G1MAQUET CARDIOPULMOARY AG
Manufacturer StreetKEHLER STRASSE 31
Manufacturer CityRASTATT, 76437
Manufacturer CountryGM
Manufacturer Postal Code76437
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVAVD CONTROLLER
Generic NameREGULATOR, VACUUM
Product CodeKDP
Date Received2015-01-29
Returned To Mfg2011-10-04
Model Number70102.4459
Catalog Number70102.4459
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMOARY AG
Manufacturer AddressKEHLER STRASSE 31 RASTATT, 76437 GM 76437


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-29

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