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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE RESCUE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformances in the production dhr related to the reported event. A getinge service territory manager (stm) was dispatched and evaluated the iabp. The stm was unable to reproduced the reported issue. The iabp passed the helium leak test and the stm performed all functional and safety checks to meet factory specifications. The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that while in use on patient, the cardiosave intra-aortic balloon pump (iabp) alarmed "low helium" after connecting the catheter extender. No patient harm or adverse event was reported.
 
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Brand NameCARDIOSAVE RESCUE
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 Key8203656
MDR Text Key131708568
Report Number2249723-2018-02236
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,user f
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-83
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/28/2017
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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