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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Output below Specifications (3004)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.The getinge field service engineer (fse) that discovered the issue replaced the scroll compressor to address the failed compressor performance test.The fse verified the performance of the compressor and completed the scheduled pm.The iabp passed all functional and safety tests to factory specifications.The unit was then returned to the customer and cleared for clinical use.(b)(6).
 
Event Description
It was reported that during preventative maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp) by a getinge field service engineer (fse), the scroll compressor was not meeting the compressor performance test and its maximum pressure was below specification.There was no patient involvement, and there was no adverse event reported.
 
Event Description
It was reported that during preventative maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp) by a getinge field service engineer (fse), the scroll compressor was not meeting the compressor performance test and its maximum pressure was below specification.There was no patient involvement, and there was no adverse event reported.
 
Manufacturer Narrative
Corrected fields: b3, g4 of initial emdr was incorrectly reported and is being corrected to (b)(6) 2019 as opposed to (b)(6) 2019.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8713692
MDR Text Key184857799
Report Number2249723-2019-00979
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
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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