MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEMOPRO 3 POWER SUPPLY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-6010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (b)(4) the device has been returned to the factory and will be evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that hemopro 3 power supply did not power on.Upon initial inspection, they were using a non-getinge power cable.They cannot locate the power cable the device was shipped with.They located another hp3 with the connected getinge power cable and connected it to the power supply.The device did not power on.There were no sounds coming from the power supply or lights on.Upon inspection, the handle/hanger at the top of the device is noted to have a full thickness crack/break.These steps and inspections were completed by the product manager.They were asked if the power supply had been dropped, and no one could confirm.There was no abnormal sounds coming from the power supply.This did not involve a patient or a surgical case.There is no patient or case data to report.Per the photo, it shows that the hanger at the top is cracked.

• Brand Name: HEMOPRO 3 POWER SUPPLY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 25650208
• Report Number: 2242352-2026-0000535
• Device Sequence Number: 20299832
• Product Code: GEI
• UDI-Device Identifier: 00607567701281
• UDI-Public: (01)00607567701281(11)250529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251238
• 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,Followup,Followup
• Report Date (Section B): 06/24/2026

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-6010
• Device Catalogue Number: VH-6010
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 08/04/2026; 08/05/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/04/2026; 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown