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

Model Number C-VH-3010

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Tw id# (b)(4).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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply failed to operate upon start up.The power supply would not turn on.Several different power cables and outlets were tried but the power supply failed to activate.The hospital biomed department ran several tests and tried several power up options and none were successful in getting the power supply to operate.Case was canceled due to failure to operate.No harm/effects to patient.

Manufacturer Narrative

Tw # (b)(4).Corrected section- h6 impact code 4632 changed to 4633.The device was returned to the factory for evaluation on 01/03/2024.An investigation was conducted on (b)(6) 2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The knob of the power supply was not observed.There were no other visual defects observed.An electrical evaluation was conducted.A reference power cord was plugged into the power supply and the device was switched on.The green lights on the power supply did not turn on.A pre-cautery test was performed per the instruction for use (ifu) with a reference adapter, hp2, cable, and power supply vh-3010 at level 3.0.The device did not pass the pre-cautery test.Based on the returned condition of the device, the reported failure "failure to deliver energy" was confirmed as well as the analyzed failure "missing component" was observed.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device serial # conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

N/a.

• Brand Name: HEMOPRO 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: 18478312
• MDR Text Key: 332642340
• Report Number: 2242352-2024-00029
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C-VH-3010
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: POWER CABLES AND OUTLETS