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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 Audible Prompt/Feedback Problem (4020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2020
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 getinge service territory manager (stm) was dispatched to evaluate the iabp and the stm reported that during the transducer test, the x1 & x2 were out of specifications.Subsequently, performed calibration of transducers and helium.The stm then checked calibration of unit, and returned to user interface to ensure no further error message produced.The unit passed all functional and safety tests per factory specifications, and the iabp was returned to the customer and cleared for clinical use.
 
Event Description
It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a failure alarm.It was later reported that the iabp emitted an audible error alarm, but no specifics were given.There was no harm or injury to the patient and no adverse event was reported.
 
Event Description
It was reported by customer that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a failure alarm.It was later reported that the iabp emitted an audible error alarm, but no specifics were given.There was no harm or injury to the patient 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 Key10248301
MDR Text Key198114360
Report Number2249723-2020-01036
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 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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