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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 Problems Retraction Problem (1536); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A getinge field service engineer (fse) was dispatched to the customer's site and after evaluating the iabp unit, was able to verify the customer's reported issue. No parts were replaced and the details of the evaluation have been requested. The fse has advised that iabp unit was cleared for clinical use and released to the customer. A supplemental report will be submitted if additional information is provided.
 
Event Description
It was reported that during use on a patient, the line cord for the cardiosave intra-aortic balloon pump (iabp) was blocked inside the cart and the length was too short to connect to ac power. The customer swapped out the iabp unit with another iabp unit to continue therapy without issue. There was no patient harm and no adverse event 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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9179522
MDR Text Key190338456
Report Number2249723-2019-01641
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2019
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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