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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 0998-00-0800-53
Device Problem Gas/Air Leak (2946)
Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.And found that the helium reservoir, high pressure regulator, regulator housing and helium tubing were all leaking.The cable for the helium regulator was corroded also.The fse replaced the 9 volt battery, helium reservoir, helium regulator, high pressure regulator, regulator housing, helium tank transducer cable, and helium tubing.The fse performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a helium leak.It is unknown the circumstances under which the event occurred.However, 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 helium leak.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involved, however, no patient harm or adverse event was reported.
 
Manufacturer Narrative
Updated fields: b4, b6, b7, g3, g4, g7, g8, h2, h6(investigation type, component codes & impact codes), h10, h11.Corrected fields: b5, d4(model#), d5, d11, g1(contact person), h6(clinical code).
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11230996
MDR Text Key228861187
Report Number2249723-2021-00147
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/08/2021
Initial Date FDA Received01/26/2021
Supplement Dates Manufacturer Received08/24/2022
Supplement Dates FDA Received08/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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