• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC T.W. POWER SUPPLY; ENDOSCOPIC VESSEL HARVESTING

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOVASCULAR, LLC T.W. POWER SUPPLY; ENDOSCOPIC VESSEL HARVESTING Back to Search Results
Model Number VH-3010
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, the t.W.Power supply provided power intermittently.The cord was changed and it still worked intermittently.The power supply was switched and the device worked fine.No patient effects were reported.Biomed dept tested the power supply and it worked fine and was put back into circulation.
 
Manufacturer Narrative
Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per out standard sop's, all events are tracked and trended to determine whether or not any trends develop.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
T.W. POWER SUPPLY
Type of Device
ENDOSCOPIC VESSEL HARVESTING
Manufacturer (Section D)
MAQUET CARDIOVASCULAR, LLC
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4239094
MDR Text Key4986625
Report Number2242352-2014-01176
Device Sequence Number1
Product Code HQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVH-3010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/06/2014
Initial Date FDA Received10/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-