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

Model Number T.W. POWER SUPPLY

Device Problems Break (1069); Crack (1135); Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using t.W.Power supply s/n (b)(4), several problems with this device.No patient effects.Missing knob.The case is separating where the hanger goes in.Near the power cord a button or connector appears to be missing or broken.Also cracks around instrument connector.They could not tell if it had been dropped.No patient involvement.

Manufacturer Narrative

Trackwise 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.

Manufacturer Narrative

Trackwise #: (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period ( feb 2020 through jan 2022) was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Device not returned: (4114/ 3221) despite request and/ or customer indicated that the device would be returned; however, no device was returned.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: 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: 13525273
• MDR Text Key: 286361702
• Report Number: 2242352-2022-00148
• 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
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1