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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per sop 01-061 since the device manufacture date is greater than one year from the event date. A getinge field service engineer (fse) was dispatched to evaluate this unit and was able to reproduce the reported failure. The fse checked the error codes and found that at the time of the issue there are multiple ¿catheter restriction alarms¿. The fse ran the unit thru a complete calibration and functional test and all meets factory specifications. The fse also ran the unit on a test balloon and trainer for approximately 45 mins and the unit worked as it should at this time, the iabp was then released for clinical use.
 
Event Description
While attempting to support a patient with a fiber optic (fo) catheter on a cardiosave intra-aortic balloon pump (iabp), the catheter would not calibrate. The iabp was pumping with augmentation present but when calibration attempted it kept giving the message no assist. There was no other console available. The customer attempted several insert and removal of fo cable with same result. Recognized fo as indicated on the screen but same result when attempting to calibrate. Switched to central lumen balloon pressure source and zeroed successfully. The catheter was removed and impella was placed for additional support. There was no patient harm and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8264809
MDR Text Key133846534
Report Number2249723-2019-00111
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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