MAUDE Adverse Event Report: Maquet Cardiovascular LLC T.W. Power Supply; Unit, Cautery, Thermal, Ac-Powered

Model Number	VH-3010
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the t.W.Power supply began malfunctioning during a cabg procedure.The issue was noticed during sputtering when delivering energy.The customer did not report any information regarding beeping tones.Exchanging the cables/adapters did not resolve the issue; however, using a different power supply did.Power setting at 3.The hemopro power supply was first put into distribution in 2015 the dates for the hemopro extension cable and adapter are unknown; therefore, their ages cannot be determined.The power supply was placed on the endoscopic tower during use.It was not located in close proximity to other power-generating devices or equipment that would be expected to generate a significant amount of electrical power or cause interference.Minor delay of 2-3 minutes.No patient harm.
Additional Manufacturer Narrative
(b)(4).Event site name exceeds character limitations: (b)(6).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.

• 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: 50852350
• Report Number: 2242352-2026-0000822
• Device Sequence Number: 21209289
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: (01)00607567700826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Unknown
• Patient Sex: Unknown