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

Model Number VH-3010

Device Problem Failure to Deliver Energy (1211)

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

Event Date 08/22/2023

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 generator never provided energy.They then switched out the generator and it worked.Power dial was on 2.5.Generator light was "green." generator didnt work from the outset.No vein issues.Procedure was delayed by 10 mins.

Manufacturer Narrative

Tw id# (b)(4).Updated section: b4, d10, g4, g7, h2, h3 h6, h10, h11.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.H3 other text : device not returned.

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: 17711273
• MDR Text Key: 322962823
• Report Number: 2242352-2023-00766
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

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: VH-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK.; VH-4030 CORD.