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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(6).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.

Event Description

The hospital reported that the t.W.Power supply was not working properly.Delivering energy/power intermittently.They changed out the cord and adapter (vh-4030 and vh-4020) and still same issue.They changed out to another vh-3010 power supply/generator to complete the case.No patient effect was reported.

Event Description

N/a.

Manufacturer Narrative

(b)(4).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.

• 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15799690
• MDR Text Key: 306518657
• Report Number: 2242352-2022-00936
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: 709407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: C-VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.