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

Model Number POWER SUPPLY

Device Problem Loss of Power (1475)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

August 21, 2015 11:46 am (gmt-4:00) added by (b)(6): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

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

Manufacturer Narrative

10/15/2015 01:58 pm (gmt-4:00) added by (b)(4): a lot history search is not applicable because this is a reusable, oem device.Due to the age of the device, a c of c is not readily available on-site.The device was returned to the factory for evaluation.There were some signs of clinical use and no evidence of blood.The device showed some signs of wear at the connector and no other non-conformities.The device manufacture date is 2006-04.The device is approximately 9 years.The device could not be evaluated for its electrical function since it would not turn on.Based on the results of the evaluation, the reported complaint for ¿failure to deliver energy¿ was confirmed.The root cause of this issue is normal and expected ¿wear and tear¿ experienced during extended service life.A fir will not be issued at this time because the reported device failure occurred well after the recommended useful life of the device (approximately 1.5 years as stated in the product specification.) due to the age of the device, a c of c is not readily available on-site.The root cause of the reported failure is undetermined because the event occurred during the use of the device and the procedural operation is unavailable for our review.

Event Description

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

• Brand Name: 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: 5024642
• MDR Text Key: 24706566
• Report Number: 2242352-2015-01013
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• PMA/PMN Number: K043155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: POWER SUPPLY
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2009
• 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