VAVD CONTROLLER 70103.5905

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2015-01-29 for VAVD CONTROLLER 70103.5905 manufactured by Maquet Cardiopulmoary Ag.

Event Text Entries

[20123340] On (b)(6) 2012 at the ssu at (b)(6) reported that the vacuum was unstable on the vacuum controller (vavd) serial number(sn): (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[20185376] (b)(4). Service report (b)(4) was generated for this event. The device was tested per the service protocol but the failure was not reproduced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010762-2014-01036
MDR Report Key4461737
Report Source00,01,06
Date Received2015-01-29
Date of Report2012-07-17
Date of Event2012-02-16
Date Facility Aware2012-07-17
Report Date2012-07-17
Date Reported to Mfgr2012-07-17
Date Mfgr Received2012-07-17
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 Mfg2012-07-16
Model Number70103.5905
Catalog Number70103.5905
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.