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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 N/A
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge service territory manager (stm) was dispatched to investigate. The stm evaluated the iabp unit, and observed a bent ground pin on the ac power cord plug. The stm replaced the ac power cord, and the power supply. In addition, the stm also replaced the safety disk as it was due to be replaced. Subsequently, the stm 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. The full name is (b)(6).
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) did not recognize that it was plugged in. There was no patient harm, and no adverse event was 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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10712063
MDR Text Key212371604
Report Number2249723-2020-01727
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
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 Received10/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2019
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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