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 11/05/2023

Event Type  malfunction  

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was an out of box failure.Power supply was cleared through biomed but then failed to provide power once placed in the or.Light flickers when turned on and multiple cables were tried to get power to evh with no success.Device was not in contact with patient.

Manufacturer Narrative

Tw id# 882412.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

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, d10, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 09/18/2023.An investigation was conducted on 09/06/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The power supply was observed to be intact.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 were faintly illuminated, indicating insufficient power was delivered to the device.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.No visible steam or heat was produced when the device was activated and no tone was audible from the power supply upon activation.Final testing of the device was conducted on 09/26/2023 using a a fluke 8846a precision multimeter bmram id# (b)(6), per mcv00030545 rev.B, equipment calibration procedure for vasoview power supply.The following results were observed: no load voltage: 2.58vdc; low current output: 0.0 amps dc; high current output: 0.0 amps dc.The voltage and current were found to be out of specification.Based on the returned condition of the device, the reported failure "failure to deliver energy" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial conforms to all applicable product specifications.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.

• 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: 17780309
• MDR Text Key: 323824856
• Report Number: 2242352-2023-00794
• Device Sequence Number: 1
• Product Code: HQO
• 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: 10/30/2023

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
• 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
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1