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 Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 12:54 pm (gmt-4:00) added by (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, the hemopro power supply lost power.The procedure was completed with another of the same device.The complaint unit was serviced at a later date and the hospital reported that the compliant device is now working fine.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4) 2015 03:19 pm (gmt-5:00) 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 certificate of conformance (c of c) is not readily available on-site.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, the hemopro power supply lost power.The procedure was completed with another of the same device.The complaint unit was serviced at a later date and the hospital reported that the compliant device is now working fine.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: 5086851
• MDR Text Key: 26475185
• Report Number: 2242352-2015-01099
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• 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?: No
• Date Manufacturer Received: 12/01/2015
• 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