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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2020
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted if subsequent information is provided.
 
Event Description
In preparation for patient transport, it was reported that the lever of the cardiosave intra-aortic balloon pump (iabp) was pulled and the console disengaged from the cart.It was also reported that the unit was operating on a full battery supply, as the console was not able to slide out fully nor slide back into the cart to engage again.Further, it was reported that the customer continued with patient transport with the entire cart and console.Moreover, the customer reported that after the patient was transported, the unit will be sent to the facility biomedical department.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.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
In preparation for patient transport, it was reported that the lever of the cardiosave intra-aortic balloon pump (iabp) was pulled and the console disengaged from the cart.It was also reported that the unit was operating on a full battery supply, as the console was not able to slide out fully nor slide back into the cart to engage again.Further, it was reported that the customer continued with patient transport with the entire cart and console.Moreover, the customer reported that after the patient was transported, the unit will be sent to the facility biomedical department.No patient harm, serious injury or adverse event was reported.
 
Event Description
In preparation for patient transport, it was reported that the lever of the cardiosave intra-aortic balloon pump (iabp) was pulled and the console disengaged from the cart.It was also reported that the unit was operating on a full battery supply, as the console was not able to slide out fully nor slide back into the cart to engage again.Further, it was reported that the customer continued with patient transport with the entire cart and console.Moreover, the customer reported that after the patient was transported, the unit will be sent to the facility biomedical department.No patient harm, serious injury or adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE I PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key11151883
MDR Text Key226271366
Report Number2249723-2021-00045
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108421
UDI-Public10607567108421
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,Followup
Report Date 04/20/2021
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 NumberN/A
Device Catalogue Number0998-00-0800-45
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/19/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received01/13/2021
04/20/2021
Supplement Dates FDA Received02/10/2021
04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient Weight60
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