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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 Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: (10 /213) a getinge field service engineer (fse) that encountered the issue, reported that connection was cracked on the blue housing. It still connected ok and tested to factory specifications. The fse ordered a replacement connector to avoid further damage. Subsequently , the connector was replaced and completed a system test. Unit passed all functional and safety test per factory specifications. The iabp was released to the customer and cleared for clinical service. The full name of the initial reporter is (b )(6). The initial reporter named is a getinge employee who has different contact details from that of the event site. Please refer to the following for a contact at the event site: (b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) has a broken fiber-optic connector. 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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12095689
MDR Text Key265582819
Report Number2249723-2021-01401
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 company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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