MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number T.W. POWER SUPPLY

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) beep is not loud enough.There was no patient harm.The event is not specific to a patient or procedure.The equipment simply does not ¿beep¿ loud enough when in use, therefore not indicating to the pa that it is active/in use.

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 an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) beep is not loud enough.The equipment simply does not ¿beep¿ loud enough when in use, therefore not indicating to the pa that it is active/in use.There is no harm or patient involvement in the sense of harm to a patient.This complaint was simply saying that the volume of the generator was not loud like their previous units.No harm to patient.

Manufacturer Narrative

Trackwise# (b)(4).Corrected section: h6- health effect ¿ impact codes- patient involved in case.The device was returned to the factory for evaluation on 05/13/2022.An investigation was conducted on 06/01/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.An electrical evaluation was conducted.A reference power cord was attached to the power supply and the device was switched on.The device was connected to a power cord and the power switch was turned to the "on" position.The device was able to be energized.The green indicator light did illuminate and the device did provided energy to a reference hemopro device and extension cable.The beep that occurs when the reference harvesting device was the normal beeping.There were no visual or audio defects observed with the sound of the power supply.Based on the returned condition of the device, and the evaluation results, the reported failure "mechanical problem- noise" was not 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 lot 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: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 14519851
• MDR Text Key: 293103248
• Report Number: 2242352-2022-00448
• Device Sequence Number: 1
• Product Code: GEI
• 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: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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: 05/13/2022
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1