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

Model Number VH-3010

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The hospital reported that the t.W.Power supply did not operate properly.The device has been in the office for a few weeks.The sales rep visited the hospital on (b)(4) 2014 and the power supply tested fine with cord and hemopro2 harvesting tool.Warren cole in the biomed dept will not let power supply pass because the unit doesn't meet the spects listed in the product service manual.A special resistor is needed to perform spec test on power supply and te hospital doesn't have access or resources to certify the unit.No additional info is available regarding hospital, pt or case.

Manufacturer Narrative

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.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; 45 barbour pond drive; wayne NJ 07470
• 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: 3868770
• MDR Text Key: 4458178
• Report Number: 2242352-2014-00517
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/11/2014

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 Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/07/2014
• 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