Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED Back to Search Results
Model Number T.W. POWER SUPPLY
Device Problem Failure to Deliver Energy (1211)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/28/2020
Event Type  malfunction  
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.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply failed to deliver energy.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 failed to deliver energy.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).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 06/25/2020.An investigation was conducted on 07/07/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed.The device was connected to a power cord and the power switch was turned to the "on" position.The device failed to energize.The green indicator light did not illuminate and the device failed to provide energy to a reference hemopro device and extension cable.Based on the results of the investigation, the reported "failure to deliver energy was confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10197719
MDR Text Key197988821
Report Number2242352-2020-00556
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/24/2020
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 NumberT.W. POWER SUPPLY
Device Catalogue NumberVH-3010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 06/03/2020
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received06/25/2020
Supplement Dates FDA Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-