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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 0998-00-0800-31
Device Problems Failure to Power Up (1476); Failure of Device to Self-Test (2937)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformance's related to the reported event were noted.A getinge service engineer evaluated the iabp.He reported that he checked all the connections as well as running full testing and calibrations.The service engineer stated that he was unable to replicate the alleged malfunction and the iabp was working within specification.
 
Event Description
It was reported that when the cardiosave intra-aortic balloon pump (iabp) was turned on, it would not start and it stated that its self-test had failed.It generated power up test fails code #14.There was 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 Key7704985
MDR Text Key114729482
Report Number2249723-2018-01222
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/17/2018
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 Other
Device Catalogue Number0998-00-0800-31
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 06/26/2018
Initial Date FDA Received07/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2017
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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