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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPEB PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPEB 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 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp unit.The stm confirmed the customer needed the transducer cable and supplied it to them.This was a parts sale only.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) transducer plug to the iabp connections do not match.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: h6 (evaluation method codes).
 
Event Description
It was reported that the connections of the transducer's plug to the cardiosave intra-aortic balloon pump (iabp) did not match.There was no patient involvement and no adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPEB PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10592775
MDR Text Key208750913
Report Number2249723-2020-01574
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,user f
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
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 Received10/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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