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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2022
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device : a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue. The fse successfully completed a simulated treatment with trainer and testing catheter without issue. Also, identified various alarms for autofill failures and gas gain alarms, pointing to a potential leak. But the unit was fully functional otherwise, without any issues. The unit however, calibrated and passed all functional and safety tests per factory specifications. Returned to customer and cleared for clinical use. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during patient use the cardiosave intra-aortic balloon pump (iabp) was giving multiple errors. The customer swapped out the unit to continue treatment. No patient harm, serious injury or adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID, TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key14249926
MDR Text Key290453090
Report Number2249723-2022-00969
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
Treatment
IAB CATHETER
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