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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
 
Manufacturer Narrative
It was reported that the customer performed the troubleshooting with the iabp reported in b5 and that they purchased a new pressure cable from the manufacturer.The iabp is still on-hold at the biomed department.A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
 
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm performed a preventive maintenance (pm), and performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then handed over to the customer in good working condition.
 
Event Description
It was reported that the end-user couldn't read blood pressure reading on the cardiosave intra-aortic balloon pump (iabp) while they connected pressure transducer into it.The end users troubleshoot themselves, and discovered that the connector was heated (which was warm/hot).The end users switched it off immediately and managed to unplug it.The end user discovered the connector was oval shaped.The pressure cable was replaced and monitoring was functional.There was no harm or injury to patient and no adverse event was reported.
 
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Brand Name
CARDIOSAVE HYBRID INT TYPE G PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10114501
MDR Text Key193639999
Report Number2249723-2020-00850
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,foreig
Type of Report Initial,Followup,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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