MAUDE Adverse Event Report: MAQUET CV T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Catalog Number C-VH-3010

Device Problem Loss of Power (1475)

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

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 09:58 am (gmt-4:00) added by (b)(6) ((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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro t.W.Power supply stopped working.A replacement device was used to complete the case.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review is not applicable.Based on the serial number provided and a review of the sales history to the account the device was sold to the distributor in december 2013, which places the age of the at approximately 1 year and 10 months.The actual service life of the device was not provided to us by the account, however, hospital reported that the device is no longer under warranty.A review of the certificate of conformity (c of c) is not applicable at this time because it is probable that the event occurred well past the specified device lifetime reliability; 1.5 years or 2340 cycles.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro t.W.Power supply stopped working.A replacement device was used to complete the case.The hospital did not report any patient effects.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5196304
• MDR Text Key: 30473792
• Report Number: 2242352-2015-01223
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/08/2016
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1