MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC. T.W. POWER SUPPLY

Model Number VH-3010

Device Problems Loss of Power (1475); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the power was intermittent on the t.W.Power supply.It would not work on a continual basis.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Since this is an oem supplied device, a lot history review is not applicable.(b)(4).

• Brand Name: T.W. POWER SUPPLY
• Type of Device: POWER SUPPLY
• 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 ; 9737097690
• MDR Report Key: 3855717
• MDR Text Key: 21445205
• Report Number: 2242352-2014-00462
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043155
• Number of Events Reported: 1
• 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: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 87