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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-XX
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2017
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, however, no further details have been provided.If any additional information is provided in the future a supplemental report will be provided.
 
Event Description
The customer reported that the cardiosave intra-aortic balloon pump's (iabp) display monitor went blank when they removed the iabp from the cart in an attempt to transport a patient by air ambulance.The customer attempted to restart the iabp and it restarted normally.There was no adverse event as a result of the alleged malfunction.
 
Manufacturer Narrative
The getinge company representative reported that the fse performed running test and was able to duplicate the reported malfunction.The fse confirmed that the display failure of the monitor due to coil code.The fse replaced cable, coil cord, mounting plate, strain relief, fork, strain relief.The iabp unit was released for clinical use.
 
Event Description
The customer reported that the cardiosave intra-aortic balloon pump's (iabp) display monitor went blank when they removed the iabp from the cart in an attempt to transport a patient by air ambulance.The customer attempted to restart the iabp and it restarted normally.There was no adverse event as a result of the alleged malfunction.
 
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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 Key7143101
MDR Text Key95927725
Report Number2249723-2017-01055
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0998-00-0800-XX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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