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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 Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) the system had an overheating error after approximately one day's use.The iabp was turned off then on again to clear the error and continued functioning with out further overheating.The cardiosave was switched with another as a precaution.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) the system had an overheating error after approximately one day's use.The iabp was turned off then on again to clear the error and continued functioning with out further overheating.The cardiosave was switched with another as a precaution.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and replaced the temperature sensor threaded probe.The iabp has not been returned to the customer or cleared for clinical use at this time, since the repairs are not yet complete.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) the system had an overheating error after approximately one day's use.The iabp was turned off then on again to clear the error and continued functioning with out further overheating.The cardiosave was switched with another as a precaution.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
The fse replaced the temperature sensor probe to address the issue.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) the system had an overheating error after approximately one day's use.The iabp was turned off then on again to clear the error and continued functioning with out further overheating.The cardiosave was switched with another as a precaution.No patient harm, serious injury or 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 Key10088081
MDR Text Key192456322
Report Number2249723-2020-00801
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,Followup
Report Date 06/08/2021
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 Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/26/2020
Supplement Dates Manufacturer Received07/24/2020
08/14/2020
08/04/2020
Supplement Dates FDA Received08/14/2020
08/24/2020
06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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