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

Model Number T.W. POWER SUPPLY

Device Problems Break (1069); Failure to Deliver Energy (1211)

Patient Problem No Patient Involvement (2645)

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 preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was not working.Upon inspection, they found cracks on outside of the frame around stainless steel housing near where it is plugged in.They said it does not look like it was dropped, but it may have been bumped against something.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot/serial conforms to all applicable product specifications.The c of c is available for review as an attachment to the record.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was not working.Upon inspection, they found cracks on outside of the frame around stainless steel housing near where it is plugged in.They said it does not look like it was dropped, but it may have been bumped against something.A replacement device was used to complete the procedure.No patient involvement.

• 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: 10400800
• MDR Text Key: 202703663
• Report Number: 2242352-2020-00704
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• 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
• Report Date: 08/13/2020

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?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1