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 08/29/2023

Event Type  malfunction  

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply did not work during gauze check prior to harvesting.Power light is blinking when power is on which it should be solid green light.No harm to patient.

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).Corrected section: h6-health effect ¿ impact codes corrected to code "2645.The device was returned to the factory for evaluation on 09/06/2023.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.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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply did not work during gauze check prior to harvesting.Power light is blinking when power is on which it should be solid green light.New device.No delay.No patient involvement.

Manufacturer Narrative

Trackwise (b)(4).Updated section: b4, g4, g7, h2, h6, h10, h11.Corrected section: h6-investigation findings (1) - removed "13" added code "706", h6- investigation conclusions removed "22" added "23" updated section: the device was returned to the factory for evaluation on 09/06/2023.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: 2.45vdc; 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.

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: 17768372
• MDR Text Key: 324131324
• Report Number: 2242352-2023-00779
• 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,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
• Date Returned to Manufacturer: 09/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 10/05/2023; 10/30/2023
• Supplement Dates FDA Received: 10/05/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose