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

Model Number T.W. POWER SUPPLY

Device Problem Failure to Deliver Energy (1211)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure t.W.Power supply s/n (b)(4).Did not turn on.The device was found to be unoperable prior to any patient contact.The lightsdid not illuminate and the device did not activate when attempted.The staff member changed out the ext cable in case that was the problem, however the power supply still did not turn on.Finally the power supply was changed out for another one and the case proceeded as usual.No injury to the patient, as there was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 10/18/2022.An investigation was conducted on 10/27/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the power supply and power cord.The power supply was observed to be intact.Thin cracks in the plastic casing of the device were observed near the adaptor port.An electrical evaluation was conducted.The returned 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 now power was delivered to the device.A pre-cautery test was performed per the instruction for use (ifu) with a reference adapter, hp2, and returned 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.The returned power cord was switched out for a reference cord and the evaluation was repeated with the same results.Based on the returned condition of the device, the reported failure "failure to deliver energy" and analyzed failure "crack" were 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.

• Brand Name: T.W. 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: 15657663
• MDR Text Key: 305604468
• Report Number: 2242352-2022-00877
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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: T.W. POWER SUPPLY
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1