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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP CARDIOSAVE; INTRA-AORTIC BALLOON PUMP
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DATASCOPE CORP CARDIOSAVE; INTRA-AORTIC BALLOON PUMP Back to Search Results
Model Number CARDISAVE
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2013
Event Type  malfunction  
Event Description
The customer reported that prior to use on a pt the iabp helium gas tank was empty.The iabp was replaced and therapy was initiated.No pt injury was reported.
 
Manufacturer Narrative
The company representative found that this was due to external helium gas leakage because the o-ring was damaged.Service rep replaced the o-ring (part number 0354-00-0208).The iabp was tested to factory specifications.It functioned normally and was returned to the customer.(b)(4).
 
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Brand Name
CARDIOSAVE
Type of Device
INTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
DATASCOPE CORP
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP
1300 macarthur blvd.
mahwah NJ 07530
Manufacturer Contact
janice pevide, mgr
wayne, NJ 07470
9737097753
MDR Report Key3721308
MDR Text Key4332374
Report Number2249723-2014-00183
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/28/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCARDISAVE
Device Catalogue Number0998-00-0800-XX
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/28/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2002
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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