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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
Catalog Number 0998-00-0800-53
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems No Patient Involvement (2645); Insufficient Information (4580)
Event Date 01/20/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit. The fse was unable to duplicate the issue. The iabp ran on a test intra-aortic balloon (iab) for three hours with no issues noted. The touchscreen and bottom display functioned as expected. The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. (b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) has squiggly lines on the bottom display. There was no patient involvement, and no adverse event 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 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11323344
MDR Text Key232337472
Report Number2249723-2021-00274
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,Followup,Followup
Report Date 04/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2018
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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