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

Model Number T.W. POWER SUPPLY

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (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, t.W.Power supply h19070123g not working correctly, it's losing energy.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply h19070123g not working correctly, it's losing energy.The hospital did not report any patient effects.

Manufacturer Narrative

Updated section: d-10, g-4, g-7, h-2, h-10 corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." corrected h-6 to reflect "electrical issue" trackwise id # (b)(6).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply h19070123g not working correctly, it's losing energy.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory on 03jun2020and evaluated on 15jun2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.No visual defects were observed.The device was evaluated for its electrical function according to the service manual (mcv00009931 section d- ¿functional tests¿ using a precision multimeter and a 0.62ohm resistor hemopro power supply test box).The test box uses the 10k ohm resistor that is built into the hemopro cable.The device passed all electrical tests performed, the led light was visible and an intermittent tone was audible when current was being measured.No smoke was observed when the power supply was turned on.The values recorded are within tolerance, based on the results of the evaluation, the reported failure mode "electrical issue¿ was not confirmed.This is a reusable oem device; therefore, a lot history/serial number review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot/serial number conforms to all applicable product specifications.The c of c is available for review as an attachment to the record.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10094088
• MDR Text Key: 192379802
• Report Number: 2242352-2020-00454
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2020

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: T.W. POWER SUPPLY
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/24/2020; 06/24/2020
• Supplement Dates FDA Received: 06/24/2020; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1