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 CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; HEART LUNG MACHINE
  • 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 CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; HEART LUNG MACHINE Back to Search Results
Model Number 70102.8582
Device Problems Device Operates Differently Than Expected (2913); Improper Alarm (2951)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
On (b)(6) 2011, the (b)(6) hospital stated, that they are experiencing false bubble detection alerts with ¼ inch tubing.Complaint: (b)(4).
 
Manufacturer Narrative
Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag, (b)(4).Reference: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HL-20 INTEGRATED PERFUSION SYSTEM
Type of Device
HEART LUNG MACHINE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
kehler strasse 31
rastatt, 7643 7
GM  76437
Manufacturer (Section G)
MAQUET CARDIOPULMONARY AG
kehler strasse 31
rastatt, 7643 7
GM   76437
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4283251
MDR Text Key15115902
Report Number8010762-2014-00514
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70102.8582
Device Catalogue NumberMCP00703693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer06/01/2011
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-