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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYP B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-65
Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2021
Event Type  malfunction  
Manufacturer Narrative
The getinge field service engineer (fse) replaced the regulator, high pressure, helium in order to resolve the leakage. However, the unit is still undergoing repairs at getinge service center with respect to an unrelated and additional issue. (b)(6). The initial reporter named is a getinge employee who has different contact details from that of the event site.
 
Event Description
It was reported that while servicing a unit during a pre-delivery inspection, the getinge field service engineer (fse) found that the cardiosave intra-aortic balloon pump (iabp) had a leakage from the high pressure regulator. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID INT TYP 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11821743
MDR Text Key251197412
Report Number2249723-2021-01007
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-65
Device Catalogue Number0998-00-0800-65
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 Received06/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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