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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED
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MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED Back to Search Results
Model Number T.W. POWER SUPPLY
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2019
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure t.W.Power supply s/n (b)(4) had an electrical issue.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure t.W.Power supply s/n (b)(4) had an electrical issue.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Updated sections: description of event or problem, device identification, premarket identification, type of report, follow up type, device evaluated by mfr, adverse event problem, concomitant medical products.Corrected sections: description of event or problem, device identification corrected s/n from (b)(4).Trackwise # (b)(4).The device was returned to the factory for evaluation (b)(6) 2019.An investigation was conducted on (b)(6) 2019.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 (mcv00009931 section d- ¿functional tests¿ 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, power supply test box mcv00010390, power supply calibration mcv00030545.The values recorded are within tolerance, based on the results of the evaluation, the reported complaint was not confirmed.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.
 
Manufacturer Narrative
Trackwise # (b)(4).Device was received.A follow up report will be submitted when evaluation is completed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure t.W.Power supply s/n (b)(4) had an electrical issue.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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 Key9261445
MDR Text Key165708480
Report Number2242352-2019-01212
Device Sequence Number1
Product Code HQO
Combination Product (y/n)N
PMA/PMN Number
K052274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberT.W. POWER SUPPLY
Device Catalogue NumberVH-3010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Was the Report Sent to FDA? Yes
Date Manufacturer Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age66 YR
Patient Weight77
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