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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-3023-64
Device Problems Failure to Sense (1559); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and found nothing in the logs but did find a fiber optic connector cut off from the orange cable.Upon reinsertion, the fse noticed a resistance a little bit more than usual but finally connected it correctly.The fse determined that the probable cause of the incident was incomplete insertion related to the unusual "hardness" found of the connector.After 2 hours of testing, the fse completed a pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) had a fiber optic fault.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a fiber optic fault.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a fiber optic fault.The unit was swapped out with another to continue therapy.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp.The fse found nothing in the logs, but did find a fiber optic connector cut at the start of the orange cable.The fse tried to connect the supplied cut connector and noticed an unusual resistance when inserting.The fse determined that the probable cause of the incomplete insertion was due to the observed unusual "hardness" of the connector.The fse tested the fiber-optic connector with a test balloon and fiber-optic test tool.No problems were observed.No functional issues were observed with the fiber-optic connector.After 2 hours of testing, the fse completed a preventive maintenance (pm) with a complete functional check.The iabp was then returned to the customer and cleared for clinical use.
 
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Brand Name
CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12697871
MDR Text Key278382734
Report Number2249723-2021-02457
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108308
UDI-Public10607567108308
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-3023-64
Device Catalogue Number0998-00-3023-64
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/1999
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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