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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS USA CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET MEDICAL SYSTEMS USA CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-83
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 03/14/2016
Event Type  malfunction  
Event Description
While in the elevator transporting pt to the 4th floor, the iabp began to emit a loud shrill noise and the screen froze. All waveforms disappeared and the balloon was not functioning nor were there any cardiac or pressure waves visible, only flat lines and no readings. The touch-screen was frozen as well, and would not respond; we were unable to start/stop/etc. One medic manually turned iabp off with power button. It was then restarted and began to function as previously set. During this time, the helium was greater than half full and battery power was half-full as well. Pt condition was unchanged throughout. The chief flight nurse and chief pm were notified. Bio-med was called by the chief nurse and the iabp was turned over to bio-med tech. Biomed called maquet for service repair, spoke to (b)(4), he will come to workshop weds. To evaluate balloon pump. The model was d998-00-0800-83.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET MEDICAL SYSTEMS USA
45 barbour pond drive
wayne NJ 07470
MDR Report Key5808191
MDR Text Key49988225
Report Number5808191
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-83
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2016
Event Location Hospital
Date Report to Manufacturer05/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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