MAUDE Adverse Event Report: Maquet Cardiovascular LLC Hemopro 3 Power Supply; Electrosurgical, Cutting & Coagulation & Accessories

Model Number	VH-6010
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw # (b)(4) updated sections: b4,b5,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 08/10/2026.An investigation was conducted on 08/10/2026.A visual inspection was conducted.The power supply was returned outside its product packaging.An r&d engineering investigation was finalized on 09/25/2026.There was no visible damage observed.The led light was green.Voltage testing was conducted: no load voltage- less than 5.45v or over 5.55v- dmm measured 5.2 v.J300 3-pin molex connector was observed to be in place.J300 3-pin odu connector- the socket accepted a 1.18 mm pin gauge, whereas a known good connector rejected.Limit gauging (using meyers gage +/- 0.0025mm) revealed that two of the three connector sockets were structurally expanded and out of tolerance.Specifically, the compromised sockets accepted a 1.18 mm pin gauge, whereas a known good connector correctly rejected a pin of that size.Laboratory testing successfully replicated the failure mechanism.The insertion of an oversized test probe deformed the connector sockets, resulting in a subsequent loss of electrical contact with the standard-sized pins of the hp3 power cable.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to deliver energy" was confirmed.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: 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: 50496627
• Report Number: 2242352-2026-0000745
• Device Sequence Number: 10631102
• Product Code: GEI
• UDI-Device Identifier: 00607567701281
• UDI-Public: (01)00607567701281(11)251020
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Supplement Date Received by Manufacturer: 10/02/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown