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 02/27/2016

Event Type  malfunction  

Manufacturer Narrative

On 03/25/2016 07:23 pm (gmt-4:00) added by (b)(6): 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.(b)(4).

Event Description

On 03/01/2016 04:12 pm (gmt-5:00) added by (b)(6): the hospital reported that during an endoscopic vein harvesting procedure, (b)(6) kept losing power.A replacement device was used to complete the procedure.The hospital did not report any patient effects.On 03/01/2016 01:07 pm (gmt-5:00) added by (b)(6): hemopro2 kept losing power and they changed generator out and it worked.I'm not sure that this is a complaint.We do not know if it was the cord, adapter or generator.They are reporting it was the generator though.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The product is not returning.A lot number was not provided and the specific product serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply kept losing power.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Hemopro2 kept losing power and they changed generator out and it worked.I'm not sure that this is a complaint.We do not know if it was the cord, adapter or generator.They are reporting it was the generator though.

• 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: 5528718
• MDR Text Key: 41546755
• Report Number: 2242352-2016-00288
• 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
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• 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?: No
• Device Age: YR
• Date Manufacturer Received: 07/05/2016
• 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