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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Inability to Auto-Fill (1044)
Patient Problem No Information (3190)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. Getinge service was not requested in connection with this event. A supplemental report will be submitted if additional information is made available.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was initiated on a patient for coronary perfusion during transport to abq for bypass. However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon. The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was initiated on a patient for coronary perfusion during transport to abq for bypass. However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon. The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly. No patient harm or serious injury was reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8237580
MDR Text Key132921099
Report Number2249723-2019-00069
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2019
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? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

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