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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 02/10/2021
Event Type  malfunction  
Manufacturer Narrative
The fse found the helium leak in the helium fill manifold assembly and has requested for the necessary parts to complete the repair. A supplemental report will be submitted when additional information is provided. (b)(4).
 
Event Description
It was reported that during installation of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge field service engineer (fse), internal leaks were observed. There was no patient involved and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE E/F 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 Key11381757
MDR Text Key233747805
Report Number2249723-2021-00423
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2020
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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