WORKMATE? CLARIS? SYSTEM COMPUTER Z620 H700977

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 2019-12-12 for WORKMATE? CLARIS? SYSTEM COMPUTER Z620 H700977 manufactured by St. Jude Medical, Inc..

Event Text Entries

[170452916] The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10


[170452917] Related manufacturer reference: 2184149-2019-00249. During a procedure, the amplifier and dws were booted and an error message? Amplifier disconnected? Was displayed and an audible alarm was noted from the dws. The devices were power cycled with no resolution and each time they were power cycled,? Database read/write/access error? Would display. A part of the procedure which was atrial fibrillation and supraventricular tachycardia with the use of the ensite system could not be performed and was postponed as the replacement workmate claris devices were unable to be prepared. Therefore, the use of a non-abbott device was required to completed only the atrial fibrillation part of the procedure.
Patient Sequence No: 1, Text Type: D, B5


[188741524] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received the cause of the reported error message and subsequent incomplete ablation could not be determined. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2184149-2019-00248
MDR Report Key9457687
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-12
Date of Report2020-03-30
Date of Event2019-11-25
Date Mfgr Received2020-03-25
Device Manufacturer Date2015-11-12
Date Added to Maude2019-12-12
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
Manufacturer StreetONE ST. JUDE MEDICAL DRIVE
Manufacturer CityST. PAUL MN 55117
Manufacturer CountryUS
Manufacturer Postal Code55117
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWORKMATE? CLARIS? SYSTEM COMPUTER Z620
Generic NameCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Product CodeDQK
Date Received2019-12-12
Model NumberH700977
Catalog NumberH700977
Lot Number5268159
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.
Manufacturer AddressONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-12

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