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

Model Number T.W. POWER SUPPLY

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

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 an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4).Would turn on (green light present) but would not burn/provide power.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Event Description

Thospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) would turn on (green light present) but would not burn/provide power.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Correction: "failure to deliver energy" changed to "electrical issue".This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The device was returned to the factory on 04oct2019 and investigated on 14nov2019.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.No visual defects were observed.The device was evaluated for its electrical function according to the service manual using a precision multimeter and a 0.62ohm resistor hemopro power supply test box.The test box uses the 10k ohm resistor that is built into the hemopro cable.The device passed all electrical tests performed, the led light was visible and an intermittent tone was audible when current was being measured.No smoke was observed when the power supply was turned on.The results of the electrical evaluation are as follows: no load voltage: 5.49 vdc, low current: 3.99 amps dc, high current: 5.98 amps dc and power supply test box mcv00010390.The values recorded are within tolerance, based on the results of the evaluation, the reported complaint was not confirmed.

• 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 07470
• MDR Report Key: 9236247
• MDR Text Key: 186163360
• Report Number: 2242352-2019-01182
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

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: VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 75