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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Failure to Zero (1683)
Patient Problem Insufficient Information (4580)
Event Date 05/25/2021
Event Type  Death  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to the customer's site. The fse o performed system checkout as required. The fse was unable to reproduce zero issue customer experienced. The iabp unit passed all functional and safety tests per factory specifications. Returned to customer and cleared for clinical use. Upon completion of our investigation, a supplemental report will be submitted.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the balloon failed to zero on the cardiosave iab pump (iabp). The customer switched pumps as the balloon was inserted and it then performed as expected. Patient had a st-elevated myocardial infarction (stemi) procedure during day and passed at 1:25 am. The death was not attributed to iabp by the facility. Please refer to related mfg report number 2248146-2021-00398 on the involved intra-aortic balloon (iab).
 
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Brand NameCARDIOSAVE HYBRID TYPE G PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12028257
MDR Text Key257109692
Report Number2249723-2021-01304
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,health
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
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?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/18/2021 Patient Sequence Number: 1
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