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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET DATASCOPE CORPORATION CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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MAQUET DATASCOPE CORPORATION CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number D998-00-0800-53
Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/12/2016
Event Type  malfunction  
Event Description
The nurse noted that the iabp diastolic blood pressure reading was from 0-10 mmhg. Message "unable to calibrate fiber optics" scrolling on the screen of the console. Patient also had a right radial atrial line that showed a normal diastolic bp range and waveform. Attempted to use pump to recalibrate pressures without success. Called maquet rep who walked staff through trouble shooting steps; all unsuccessful. Maquet rep then recommended switching out the pump. The pump was changed and the diastolic pressure was then reading appropriately. Manufacturer response for iabp, (brand not provided) (per site reporter): checked unit with both trainer and mini-sim with ecg and pressure cable attached. Checked fiberoptic circuit for proper function. Checked calibration at start of autofill.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
MAQUET DATASCOPE CORPORATION
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key5754523
MDR Text Key48319736
Report Number5754523
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 06/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberD998-00-0800-53
Other Device ID NumberDR227945B6
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2016
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer06/24/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/28/2016 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS
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