T.W. POWER SUPPLY VH-3010

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 2020-03-27 for T.W. POWER SUPPLY VH-3010 manufactured by Maquet Cardiovascular Llc.

Event Text Entries

[185279277] Trackwise id#(b)(4). 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


[185279278] The hospital reported that during an endoscopic vein harvesting procedure, t. W. Power supply was providing the normal audible tone when the clinician engaged the power button. After a few minutes, the generator started making a rapid tone and not the normal tone. It appeared that the device (vh-4000) did not work as efficiently when this tone was sounding. 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 Number2242352-2020-00321
MDR Report Key9889182
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-26
Date of Event2020-03-05
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-27
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 NameT.W. POWER SUPPLY
Generic NameUNIT, CAUTERY, THERMAL, AC-POWERED
Product CodeHQO
Date Received2020-03-27
Model NumberT.W. POWER SUPPLY
Catalog NumberVH-3010
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 2020-03-27

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