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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
Catalog Number 0998-00-0800-53
Device Problem Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse noted the fiber-optic connector damage and replaced it.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a damaged fiber-optic connector.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a damaged fiber-optic connector.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.
 
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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 Key11060489
MDR Text Key225339645
Report Number2249723-2020-02204
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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