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 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

(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 t.W.Power supply would not turn on when plugged in.The generator was not used in a case.They unplugged the power supply/generator placed it aside then plugged in a new generator/power supply, worked fine.No patient contact.

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 10/06/2023.An investigation was conducted on 10/10/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.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 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.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: 17886070
• MDR Text Key: 326033651
• Report Number: 2242352-2023-00826
• 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: 10/16/2023

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: 09/14/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1