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

Model Number T.W. POWER SUPPLY

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(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 was not working.They brought it to the or and tested it with a hemopro device and confirmed that the ps was not working.They also turned it off and on a few times and it did not work.No patient involvement.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory on 10/12/2020.An investigation was conducted on 10/29/2020.A visual inspection was conducted.Even though it was reported there was no patient involvement.Signs of clinical use and slight evidence of blood was observed on the plug end of the power supply.A slight crack was observed just above the connector port.No other visual defects were observed.An electrical evaluation was conducted.The device was connected to a power cord and the power switch was turned to the "on" position.The device failed to energize.The green indicator light did not illuminate and the device failed to provide energy to a reference hemopro device and extension cable.Based on the results of the investigation, the reported "failure to deliver energy was confirmed as well as for the analyzed failure "crack".The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply was not working.They brought it to the or and tested it with a hemopro device and confirmed that the ps was not working.They also turned it off and on a few times and it did not work.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: 10656613
• MDR Text Key: 210655147
• Report Number: 2242352-2020-00864
• 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: 10/07/2020

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: 10/12/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1