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

Model Number	VH-3010
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported the t.W.Power supply functioned for a period of time before becoming intermittent, and ultimately failed completely during a procedure.It's unknown if the pre-test was done.The extension cable was changed, and the issue persisted.It's unknown if the device shut off after 15 seconds.Polyfuse does not have a user indicator.Continued with intermittent power.Power setting at 3.No change in power settings attempted.The age of the adaptor cable and extension cable is unknown.The power supply is on tower with other equipment.No procedural delay aside from time to troubleshoot with changed cords, and then bringing in a different vh-3010.The vh-3010 failed the service power tests preformed by biomed.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (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.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
• Common Device Name: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 25193074
• Report Number: 2242352-2026-0000362
• Device Sequence Number: 10097174
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: (01)00607567700826(11)H14120024G
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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
• Operator of Device: Health Professional
• Device Model Number: VH-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown