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 Insufficient Information (4580)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) stopped working.Will not power on.Used a different generator to complete the case.

Manufacturer Narrative

Tw id# (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/12/2024.An investigation was conducted on 03/14/2024.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 not illuminated, indicating no 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 returned 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.An engineer evaluation and final testing of the power supply was conducted on 04/02/2024 using a a fluke 8846a precision multimeter bmram id# (b)(4), per mcv00030545 rev.B, equipment calibration procedure for vasoview power supply.The following results were observed: no load voltage: 0.00vdc; low current output: 0.00 amps dc; high current output: 0.00 amps dc.The complaint vasoview hemopro power supply failed all three output tests confirming that this power supply is malfunctioning and unable to deliver energy.Additionally, it was observed during the testing, that the led power-on indicator and led indicator light located next to extension cable connector were not illuminating which is not normal.The power supply was opened up to examine the inner circuitry and it was observed that the ac power connector was disconnected from the bear board.See attached engineer evaluation and supplier quality engineer email chains.Based on the returned condition of the device and engineer evaluation, 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.

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: 18963521
• MDR Text Key: 338614625
• Report Number: 2242352-2024-00285
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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 Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.