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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problems Malposition of Device (2616); Charging Problem (2892)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2017
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.The company service territory manager (stm) evaluated the iabp and confirmed the batteries were not charging and issues with right side battery ejecting from the iabp.The stm replaced the power slot management board verifying bent pin.The battery in slot one then registered and started charging, but battery in slot two did not register.The stm checked all connections, but battery two still not registering.The stm changed the power management board and changed the two li-ion battery packs.The battery in slot two then registered and started charging.The stm completed chapter 4 as per factory specifications.The iabp then passed all calibration and function checks.Returned to customer and cleared for clinical use.
 
Event Description
The customer reported that the cardiosave intra aortic balloon pump (iabp) batteries won't hold a charge and won't stay in place.Incident occurrence not reported.No patient involvement or adverse event reported.
 
Event Description
The customer reported that the cardiosave intra aortic balloon pump (iabp) batteries won't hold a charge and won't stay in place.Incident occurrence not reported.No patient involvement or adverse event reported.
 
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Brand Name
CARDIOSAVE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7068274
MDR Text Key93685890
Report Number2249723-2017-00894
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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