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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
Model Number N/A
Device Problems Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2018
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 company standard operating procedure since the device manufacture date is greater than one year from the event date. A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) will not boot up, the arrow continuously spins until "system failure alarm" sounds. This event occurred during a routine daily check performed by the customer. There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
A getinge service territory manager (stm) evaluated the iabp and found defective display coiled cable. To resolve the issue, the stm replaced the coiled cable and verified proper boot up function. The stm also found that the helium tank was empty, the console cover was damaged and was pushing against the 300 psi check valve causing it to crack the valve. To resolve these issues, the stm replaced the 300 psi check valve and the console cover. In addition, the stm observed that the critical alarm battery was not functioning and also replaced the critical alarm battery. All functional and electrical safety test were performed and the iabp passed all tests and was cleared for clinical use.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) will not boot up, the arrow continuously spins until "system failure alarm" sounds. This event occurred during a routine daily check performed by the customer. There was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, 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 Key7525397
MDR Text Key108908662
Report Number2249723-2018-00847
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,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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