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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 06/29/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) instructed the customer via telephone to replace the helium tank with a known full helium tank.The customer then verified that helium was displayed on iabp screen and verified that the issue was resolved.
 
Event Description
It was reported that during a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) was not recognizing the new helium tank.There was no patient involved and no adverse event was reported.
 
Manufacturer Narrative
Updated fields: b4, g4, g7, h2, h6(evaluation method codes), h10.
 
Event Description
It was reported that during a routine check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) was not recognizing the new helium tank.There was no patient involved and no adverse event was 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 Key10302020
MDR Text Key199696385
Report Number2249723-2020-01118
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
Type of Report Initial,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
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? No
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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