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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.The customer did not provide the model name/number or serial number of the iabp involved.However, a getinge representative has advised that the customer has not alleged a malfunction of the iabp, no repairs are needed and that the iabp is working well.If additional information is provided, a supplemental report will be provided.No reported malfunction.
 
Event Description
It was reported that during cardiosave intra-aortic balloon pump (iabp) therapy, there was a possible insertion in false-lumen, and entrapment of the sensation plus 50cc intra-aortic balloon catheter (iabc) in the patient.However, at the time of this report, the patient was alive.There was no reported malfunction of the iabp, and the facility has advised that the patient's injury is not attributed to the iabp.Refer to mfg report # 2248146-2019-00640 for information on the involved iabc.
 
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Brand Name
CARDIOSAVE HYBRID
Type of Device
SYSTEM, 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 Key8847304
MDR Text Key152904638
Report Number2249723-2019-01188
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 07/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received07/31/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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